Department of Health and Human Services October 2011 – Federal Register Recent Federal Regulation Documents

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Chronic Fatigue Syndrome Advisory Committee (CFSAC) will hold a meeting. The meeting will be open to the public.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection burden of the Animal Generic Drug User Fee Cover Sheet Form FDA 3728 that further implements certain provisions of the Animal Generic Drug User Fee Act of 2008 (AGDUFA).

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: ``Evaluation of the Technical Assistance to ARRA Complex Patient Grantees Project.'' 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 August 3rd, 2011, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Deborah Martinez Seldon from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Seldon was convicted of multiple felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Ms. Seldon was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Seldon failed to respond. Ms. Seldon's failure to respond constitutes a waiver of her right to a hearing concerning this action.

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.

The Food and Drug Administration (FDA) is announcing the Web site location where the Agency will post a list of guidance documents the Center for Devices and Radiological Health (CDRH) is considering for development. In addition, FDA has established a docket where stakeholders may provide comments and/or draft language for those topics as well as suggestions for new or different guidances.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.

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.).

In accordance with the National Environmental Policy Act, the National Institutes of Health (NIH), an agency of the Department of Health and Human Services (HHS), is issuing this notice to advise the public that an environmental impact statement will be prepared for the NIH Animal Center at Poolesville Master Plan, Poolesville, Montgomery County, Maryland. For Further Information Contact: Valerie Nottingham, Chief, Environmental Quality Branch, Division of Environmental Protection, Office of Research Facilities, NIH, B13/2S11, 9000 Rockville Pike, Bethesda, Maryland 20892, telephone 301-496-7775; fax 301-480-8056; or e-mail nihnepa@mail.nih.gov. Supplementary Information: The NIH Animal Center is located on 513 acres 4 miles southwest of the City of Poolesville, a small agricultural community located in western Maryland. The campus is a component of the National Institutes of Health (NIH), one of the world's largest biomedical research facilities and the Federal government's focal point for medical and behavioral research. The NIH Animal Center at Poolesville is a major extension of animal holding and production facilities at Bethesda and consists of a number of buildings used to house, quarantine, and study the behavior and immunological conduct of a variety of animal models. The NIH Animal Center at Poolesville conducts and supports research protocols for various Institutes and Centers, which includes the studies of animal behavior, conduct of immunologic procedures and sampling, and surgical investigation. Total building space on the campus amounts to approximately 364,507 gsf. Approximately 199 people work at the NIH Animal Center site. A Master Plan is an integrated series of documents that present in graphic, narrative, and tabular form the current composition of NIH campuses and the plan for their orderly and comprehensive development over a 20-year period. The plan provides guidance in coordinating the physical development of NIH campuses, including building locations, utility capacities, road alignments, parking facilities, and the treatment of open spaces. General design guidelines are also used to provide detailed guidance for the placement and design of physical improvements. The proposed action is to develop a long-range physical master plan for the NIH Animal Center. The plan will cover a 20-year planning period and address the future development of the NIH Animal Center site, including placement of future construction; vehicular and pedestrian circulation on- and off-campus; parking within the property boundaries; open space in and around the campus; required setbacks; historic properties; natural and scenic resources; noise; and lighting. The plan will examine potential growth in the NIH Animal Center personnel, and consequent construction of space over the planning period. Future construction on the site could include such facilities as: new animal holding, research laboratories, and support facilities. In accordance with 40 CFR 1500-1508 and DHHS environmental procedures, NIH will prepare an Environmental Impact Statement (EIS) for the proposed master plan. The EIS will evaluate the impacts of the master plan should development occur as proposed. Among the items the EIS will examine are the implications of the master plan on community infrastructure, including, but not limited to, utilities, storm water management, traffic and transportation, and other public services. To ensure that the public is afforded the greatest opportunity to participate in the planning and environmental review process, the NIH is inviting oral and written comments on the master plan and related environmental issues. The NIH will be sponsoring a public Scoping Meeting to provide individuals an opportunity to share their ideas on the master planning effort, including recommended alternatives and environmental issues the EIS should consider. The meeting is planned for 6:30 p.m. to 9 p.m. on October 25, 2011 at the Town Hall Building at 19721 Beall Street, Poolesville, Maryland 20837. All interested parties are encouraged to attend. The NIH has established a 30-day public comment period for the scoping process. Scoping comments must be postmarked no later than November 18, 2011 to ensure they are considered. All comments and questions on the EIS should be directed to Valerie Nottingham at the address listed above, telephone 301-496-7775; fax 301-480-8056; or e- mail nihnepa@mail.nih.gov.