Office of the Secretary 2011 – 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: Nicola Solomon, Ph.D., University of Michigan Medical School: Based on an investigation conducted by the University of Michigan Medical School (UMMS) and a preliminary analysis conducted by ORI, ORI found that Dr. Nicola Solomon, former postdoctoral scholar, Department of Human Genetics, UMMS, engaged in research misconduct in research supported by the National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), grants R37 HD030428 and R01 HD034283. Specifically, the Respondent did not perform DNA sequencing on 202 cDNA clones of homeobox genes to confirm their identity and integrity. Through multiple revision of the manuscript, the Respondent did not discuss this with the corresponding author or question and correct the corresponding author's addition of text indicating that the clones had been fully sequenced and were full length or longer (as indicated in Table 3) when compared to NCBI Mus musculus Unigene. This text supported the use of the Cap-Trapper technique to produce full length clones for the discovery of new genes without polymerase chain reaction (PCR). Both the Respondent and the U.S. Public Health Service (PHS) are desirous of concluding this matter without further expenditure of time and other resources and have entered into a Voluntary Settlement Agreement to resolve this matter. This settlement is not an admission of liability on the part of the Respondent. Respondent and ORI agreed to settle this matter as follows: (1) Respondent agreed that for a period of two (2) years beginning on September 16, 2011, prior to the submission of an application for PHS support for a research project on which her participation is proposed in a research capacity, and prior to her participation in this capacity on PHS-supported research, Respondent shall ensure that a plan for supervising her duties is submitted to ORI for approval; the supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agreed that she shall not participate as a researcher 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) Respondent agreed to exclude herself 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 two (2) years, beginning on September 16, 2011.

Pursuant to Section 10 (a), Public Law 92-463, on September 26, 2011 (76 FR 59388-59389) the Department of Defense Military Family Readiness Council (MFRC) announced a meeting to be held on October 17, 2011. This notice announces that the meeting date and time has been changed to November 21, 2011, from 2 p.m. to 4 p.m. All other information in the original notice remains the same. The meeting is open to the public, subject to the availability of space. Persons desiring to attend may contact Ms. Melody McDonald at 571-256-1738 or e-mail FamilyReadinessCouncil@osd.mil no later than 5 p.m. on Tuesday, November 15, 2011 to arrange for parking and escort into the conference room inside the Pentagon. Interested persons may submit a written statement for consideration by the Council. Persons desiring to submit a written statement to the Council must notify the point of contact listed below no later than 5 p.m., Wednesday, November 16, 2011.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Shamarendra Sanyal, PhD Duke University: Based on an inquiry conducted by Duke University (Duke), admissions by the Respondent, and additional analysis conducted by ORI in its oversight review, ORI and Duke found that Dr. Shamarendra Sanyal, former postdoctoral scholar, Duke, engaged in research misconduct by falsifying data in a grant application submitted to the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Specifically, ORI found that the Respondent falsified Figure 2C of grant application 1 R01 HL107901-01, ``Store-operated calcium entry in airway inflammation,'' by altering the gain settings in the instrument used to measure store-operated current (SOC) densities in a whole cell patch clamp experiment comparing Stim 1+/- mouse airway cells and wild type mouse airway cells. Respondent also falsified the calcium response data in Figure 5A (right panel) of the grant application referenced above by adding ATP as a reagent to the mouse airway epithelial cells to sharpen the results purported to be caused by PGN without disclosing that ATP had been added and without disclosing that ATP was not added to the control sample. The questioned research was not submitted for publication. Dr. Sanyal has entered into a Voluntary Settlement Agreement with ORI and Duke, in which he voluntarily agreed to the administrative actions set forth below. The administrative actions are required for two (2) years beginning on the date of Dr. Sanyal's employment in a research position in which he receives or applies for PHS support on or after the effective date of the Agreement (September 16, 2011); however, if he has not obtained employment in a research position in which he receives or applies for PHS support within three (3) years of the effective date of the Agreement, the administrative actions set forth below will no longer apply. Dr. Sanyal has voluntarily agreed: (1) To have his research supervised as described below and to notify his employer(s)/institutions(s) of the terms of this supervision; Respondent agrees to ensure that prior to the submission of an application for PHS support for a research project on which Respondent's participation is proposed and prior to Respondent's participation in any capacity on PHS supported research, the institution employing him will submit a plan for supervision of Respondent's duties to ORI for approval; the plan for supervision must be designed to ensure the scientific integrity of Respondent's research contribution; Respondent agrees that he will not participate in any PHS supported research from the effective date of this Agreement until a plan for supervision is submitted to and approved by ORI; Respondent agrees to be responsible for maintaining compliance with the agreed upon plan for supervision; (2) that any institution employing him must submit, in conjunction with each application for PHS funds, or report, manuscript, or contract 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 (3) 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.

On September 22, 2011 (76 FR 58786), the Defense Acquisition University Board of Visitors announced a meeting to be held Thursday, October 13, 2011, from 8:30 a.m. to 11:45 a.m. at the Hirsch Center, Building 226, Defense Acquisition University, 9820 Belvoir Road in Fort Belvoir, Virginia. Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces that this meeting is cancelled due to scheduling conflicts.

In this final rule, the Department of the Treasury makes technical corrections to an appendix to its regulations regarding disclosure of records. These amendments update the name of the former Bureau of Alcohol, Tobacco and Firearms to the Alcohol and Tobacco Tax and Trade Bureau, and also update the contact information for the Alcohol and Tobacco Tax and Trade Bureau and the procedures by which individuals may request disclosure of information under the Privacy Act. These amendments do not change the Department's interpretation of any regulation or the requirements of any recordkeeping provision.

The Defense Science Board will meet in closed session on October 26 and October 27, 2011; at the Johns Hopkins University Applied Physics Laboratory, 11100 Johns Hopkins Road, Laurel, MD 20723. The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At this meeting, the Board will discuss interim finding and recommendations resulting from ongoing Task Force activities. The Board will also discuss plans for future consideration of scientific and technical aspects of specific strategies, tactics, and policies as they may affect the U.S. national defense posture and homeland security.

The National Security Agency (NSA) is proposing to amend a system of records notice in its existing inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The Department of Homeland Security published a document in the Federal Register of September 26, 2011, regarding the appointment of the members of the Senior Executive Performance Review Boards. This correction adds the names of three individuals who were omitted from the listing.

The Office of the Secretary of Defense proposes to add a system of records to its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Scott Weber, Ed.D., MSN, University of Pittsburgh: Based on the letters from the Research Integrity Officer at the University of Pittsburgh (UP), ORI's oversight review, and an admission by the Respondent, ORI found that Dr. Scott Weber, former Assistant Professor, Health and Community Systems, School of Nursing, UP, engaged in research misconduct by (1) plagiarizing text and falsifying data from two publications supported by U.S. Public Health Service (PHS) funding (P30 MH60570; HS5 SM52671; PHS employee generated article) in two unpublished manuscripts, and (2) including significant portions of that plagiarized text in two grant applications to the National Institutes of Health (NIH) (1 L30 NR010444-01; 1 R03 HD062761-01). ORI found that the Respondent engaged in research misconduct by plagiarizing text, falsifying data and references, and fabricating data from two publications (Mufson, L., Dorta, K.P., Wickramaratne, P., Nomura, Y., Olfson, M., Weissman, M.M. ``A randomized effectiveness trial of interpersonal psychotherapy for depressed adolescents.'' Arch Gen Psychiatry 61(6):577-84, 2004 June; hereafter referred to as ``Mufson et al. 2004;'' and Cho, M.J., Mo[sacute]cicki, E.K., Narrow, W.E., Rae, D.S., Locke, B.Z., Regier, D.A. ``Concordance between two measures of depression in the Hispanic Health and Nutrition Examination Survey.'' Soc Psychiatry Psychiatr Epidemiol. 28(4):156-63, 1993 August; hereafter referred to as ``Cho et al., 1993'') supported by PHS in two journal article submissions. Specifically, ORI found that the Respondent plagiarized more than 90 percent of the text from Mufson et al. 2004 in a manuscript entitled ``A randomized effectiveness trial of psychiatric-mental health nurse practitioner-administered interpersonal psychotherapy for sexual minority adolescents with depression in primary care clinics'' and submitted to the Journal of the American Academy of Nurse Practitioners (JAANP MS). Furthermore, the Respondent plagiarized approximately 66 percent of the text from Cho et al. 1993 in a manuscript entitled ``Assessing the diagnostic predictive power of a screening tool for depression: Concordance between the CES-D and DIS in the Parent Identity Survey'' and submitted to the Journal of GLBT Family Studies (JGMS MS). In both manuscripts, the Respondent falsified and fabricated tables and figures by using all or nearly all of the data in tables and graphs from the plagiarized articles while altering numbers and changing text to represent data as if from another subject population; he also copied most of the original bibliographic references but falsified 35% of the copied references from JAANP MS and 25% of the copied references from JGMS MS, by changing volume numbers and/or publication years, apparently to hinder detection of the plagiarism. The data fabrication occurred when the Respondent altered or added values to Table 2 in each manuscript describing the demographic characteristics of the study population that was never studied. ORI also finds that the Respondent engaged in research misconduct by plagiarizing text from Cho et al. 1993 in two NIH grant applications (1 L30 NR010444-01 and 1 R03 HD062761-01) by copying substantial word- for-word portions of the text describing the test instrument to be used in the proposed study without citing the Cho et al. 1993 paper. Dr. Weber has voluntarily agreed for a period of three (3) years, beginning on September 7, 2011: (1) To exclude himself 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''); and (2) 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.

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the Office of the Secretary, Office of the National Coordinator for Health Information Technology (ONC), HHS has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et. seq.).

This notice announces the publication of an updated list of goodsalong with countries of originthat the Bureau of International Labor Affairs (ILAB) has reason to believe are produced by child labor or forced labor in violation of international standards. ILAB is required to develop and make available to the public the List pursuant to the Trafficking Victims Protection Reauthorization Act (TVPRA) of 2005.

Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces the following Federal advisory committee meeting of the Defense Business Board (DBB).

The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, ``Miner's Claim for Benefits Under the Black Lung Benefits Act and Employment History,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).

On Wednesday, September 21, 2011, the DHS Privacy Office announced in the Federal Register at 76 FR 58524 that the Data Privacy and Integrity Advisory Committee would meet on October 5, 2011, in Arlington, Virginia. This notice supplements that original meeting notice.

This notice announces the appointment of the Department of Defense, Fourth Estate, Performance Review Board (PRB) members, to include the Joint Staff, Defense Field Activities, the U.S. Court of Appeals for the Armed Forces and the following Defense Agencies: Defense Advance Research Projects Agency, Defense Contract Management Agency, Defense Commissary Agency, Defense Security Cooperation Agency, Defense Legal Services Agency, Defense Logistics Agency, Defense Threat Reduction Agency, Missile Defense Agency, and Pentagon Force Protection Agency. The publication of PRB membership is required by 5 U.S.C. 4314(c)(4). The PRB shall provide fair and impartial review of Senior Executive Service and Senior Professional performance appraisals and make recommendations regarding performance ratings and performance awards to the Deputy Secretary of Defense.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.

The Department of Homeland Security is giving concurrent notice of a newly established system of records pursuant to the Privacy Act of 1974 for the ``Department of Homeland Security U.S. Citizenship and Immigration Services-016 Electronic Immigration System-3 Automated Background Functions System of Records'' and this proposed rulemaking. In this proposed rulemaking, the Department proposes to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

In accordance with the Privacy Act of 1974, the Department of Homeland Security proposes to establish a new Department of Homeland Security system of records titled, ``Department of Homeland Security/ U.S. Citizenship and Immigration Services-014 Electronic Immigration System-1 Temporary Accounts and Draft Benefit Requests System of Records.'' This system of records allows the Department of Homeland Security/U.S. Citizenship and Immigration Services to collect and maintain records on an individual as he or she creates a temporary electronic account and/or drafts a benefit request for submission through U.S. Citizenship and Immigration Services Electronic Immigration System. This newly established system will be included in the Department of Homeland Security's inventory of record systems.

In accordance with the Privacy Act of 1974, the Department of Homeland Security proposes to establish a new Department of Homeland Security system of records titled, ``Department of Homeland Security/ U.S. Citizenship and Immigration Services016 Electronic Immigration System-3 Automated Background Functions System of Records.'' This system of records will allow the Department of Homeland Security/U.S. Citizenship and Immigration Services to collect and maintain certain biographic information about individuals in the U.S. Citizenship and Immigration Services Electronic Immigration System and its legacy systems in order to detect duplicate and related accounts and identify potential national security concerns, criminality, and fraud to ensure that serious or complex cases receive additional scrutiny. Additionally, the Department of Homeland Security is issuing a Notice of Proposed Rulemaking elsewhere in the Federal Register, to exempt this system of records from certain provisions of the Privacy Act. This newly established system will be included in the Department of Homeland Security's inventory of record systems.

This notice is to advise interested parties of a Military Health System demonstration project entitled ``TRICARE Demonstration Project for the Philippines.'' The purpose of this demonstration is to validate an alternative approach to providing healthcare services for those beneficiaries covered under the TRICARE Standard option in the Philippines, controlling costs, eliminating any balance billing issues, and ensuring that the billing practices comply with regulatory requirements. Under this demonstration, the overseas contractor in the Philippines will establish a dedicated list of providers in the Philippines who will file their claims with the contractor and be reimbursed under an established fee schedule. The providers will adhere to the quality of care requirements of the overseas contract. The beneficiaries will have overall lower costs because these providers will no longer require payments at the time of service nor will they subject beneficiaries to balanced billing of charges. Because of the geographic conditions in the Philippines and the realization that providers of the required specialties are not available in all areas, the contractor will not be required to develop a list of providers in all areas. However, in those areas where the contractor is able to develop a sufficient list of providers then all TRICARE Standard beneficiaries residing in those areas of the Philippines will be required to use these providers in order for their claims to be paid. Notice will be provided to the beneficiaries informing them of the areas participating and not participating in this demonstration.

The Department of Labor (DOL) is submitting the Office of Federal Contract Compliance Programs (OFCCP) sponsored revised information collection request (ICR) titled, ``Office of Federal Contract Compliance Programs Recordkeeping and Reporting Requirements Supply and Service,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).