Department of Health and Human Services January 2009 – Federal Register Recent Federal Regulation Documents

HHS gives notice of a decision to designate a class of employees at the Metallurgical Laboratory in Chicago, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On January 16, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees at Vitro Manufacturing in Canonsburg, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On January 16, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: M. Nguyen, M.D., University of California, Los Angeles: Based on a University of California, Los Angeles (UCLA) report and Respondent's own admission, the U.S. Public Health Service (PHS) found that Dr. M. Nguyen, former Associate Professor at UCLA, engaged in scientific misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant 1 R01 CA69433, National Center for Complementary and Alternative Medicine (NCCAM), NIH, grant 1 P50 AT00I51-01, and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant T32 DK03688. Specifically, PHS found that Respondent engaged in scientific misconduct by: 1. Dr. Nguyen's laboratory conducted a single experiment on the effect of Livistona extract on the growth of 10\6\ mouse fibrosarcoma (FSA) cells injected into C3H mice. The drug was administered in the drinking water of the treated mice and tumor sizes were measured twice weekly with calipers. Dr. Nguyen falsified and fabricated the results of this experiment in Figure 3 of Oncology Reports 8:1355-1357, 2001: A. The data reported for the control group were from an experiment in nude mice implanted with human breast tumor implants, rather than with mouse fibrosarcoma cell implants, as Dr. Nguyen reported in the paper. The control data for FSA implanted C3H mice could not be located in the laboratory records. 2. Dr. Nguyen's laboratory conducted a single experiment on the effect of Livistona extract on the growth of 10\8\ MDA-MD-231 cells injected into nude mice. The drug was administered in the drinking water of the treated mice and tumor sizes measured twice weekly with calipers. Dr. Nguyen falsified and fabricated the results of this experiment in Figure 9 of NIH grant application P50 AT00151-01, dated May 19, 1999, by: A. Falsely stating in the associated text that there were ten mice per group and that the experiments were repeated once, while in fact, there were only five mice per group with no repetition of this experiment B. Omitting data on the control curve for two of the measurement times (at 2 and 3.5 weeks) and falsely reporting the times at which three other measurements were taken. 3. Dr. Nguyen's laboratory conducted a single experiment (1998-99) testing the anti-angiogenic effects of Livistona chinensis extract on human umbilical vein endothelial cells (HUVEC). HUVEC cells were counted from duplicate wells when exposed to extract and controls were counted from single wells: A. Figure 8 of NIH grant application P50 AT00I51-01, dated 5/19/99, plots the data as a bar graph. However, the same data were reported in Figure 1 of Oncology Reports 8:1355-1357, 2001, by falsely expressing them as the rate of growth obtained by measuring the uptake of radioactive thymidine into cellular DNA and plotting the data as normalized to control values. UCLA concluded that Figure 1 was falsified by claiming the data were obtained by a state-of-the-art technique not actually employed by the Respondent to obtain the data for that figure (Admission). This falsification did not bear upon the findings of the paper. 4. Dr. Nguyen's laboratory tested whether the levels of bFGF (basic fibroblast growth factor) and VEGF (vascular endothelial growth factor) in nipple fluid aspirates were significantly elevated in breast cancer patients in comparison to values from normal lactating and non- lactating breasts. Dr. Nguyen falsified the number of subjects who were lactating in The Lancet 356:567-569, 2000, by claiming that bFGF data were obtained from four separate subjects while in fact the data were from both breasts of two subjects. Dr. Nyugen has entered into a Voluntary Settlement Agreement with ORI. As part of that Agreement, Dr. Nyugen admits to UCLA's findings of fact but denies ORI's findings that the actions rise to the level of scientific misconduct. The settlement is not an admission of liability on the part of the Respondent. Dr. Nyugen voluntarily agreed, for a period of three (3) years, beginning on December 29, 2008: (1) Not to serve 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; and (2) That although Respondent is not currently engaged in PHS- supported research, any institution that submits an application for PHS support for a research project on which the Respondent's participation is proposed or that uses the Respondent in any capacity on PHS supported research, or that submits a report of PHS-funded research in which the Respondent is involved, must concurrently submit a plan for supervision of the Respondent(s duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of the Respondent(s research contribution. Respondent agreed to ensure that a copy of the supervisory plan also is submitted to ORI by the institution for ORI approval. Respondent agreed to not participate in any PHS-supported research until such a supervisory plan is submitted to ORI.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Allergenic Products Advisory Committee;Blood Products Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; and the Vaccines and Related Biological Products Advisory Committee. Nominations will be accepted for current vacancies and those that will or may occur through September 30, 2009. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case: Nima Afshar, PhD., University of California, San Francisco: Based on a University of California, San Francisco (UCSF) report and Respondent's own admission, the U.S. Public Health Service (PHS) found that Dr. Nima Afshar, former postdoctoral fellow at UCSF engaged in research misconduct in research supported by National Cancer Institute (NCI), National Institutes of Health (NIH), grant T32 CA108462 and National Institute of General Medical Sciences (NIGMS), NIH, grant R01 GM59704. PHS found that Respondent engaged in research misconduct in the performance of research on yeast to test whether disruption of the tight controls, to prevent re-replication, on the initiation of DNA replication could produce gene amplifications with a copy number greater than two (2). Specifically, Respondent falsified files containing raw scanned microarray images from another researcher's experiments to demonstrate that in experiments that she claimed to have conducted, she successfully observed gene amplifications with a copy number greater than two (2); there were 36 such instances of falsifying data files. Dr. Afshar has entered into a Voluntary Settlement Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on December 22, 2008: (1) 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; and (2) 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 the Respondent in any capacity on PHS supported research, or that submits a report of PHS-funded research in which the Respondent is involved, must concurrently submit a plan for supervision of the Respondent's duties to the funding agency for approval. The supervisory plan must be designed to ensure the scientific integrity of the Respondent's research contribution. Respondent agrees to ensure that a copy of the supervisory plan also is submitted to ORI by the institution for ORI approval. Respondent agrees that she will not participate in any PHS-supported research until such a supervisory plan is submitted to ORI.

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: ``Assessing Organizational Responses to AHRQ's Health Literacy Pharmacy Tools.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invitesthe public to comment on this proposed information collection.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-NEW, ``Indian Health Service Director's Three Initiative Best Practice, Promising Practice, and Local Effort Form.'' Type of Information Collection Request: Three year approval of this new information collection, 0917-NEW, ``Indian Health Service Director's Three Initiative Best Practice, Promising Practice, and Local Effort (BPPPLE) Form.'' Form(s): The Indian Health Service BPPPLE form. Need and Use of Information Collection: The Indian Health Service (IHS) goal is to raise the health status of the American Indian and Alaska Native (AI/ AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the HiS mission, the Director's Three Initiative was launched which is comprised of Health Promotion and Disease Prevention (HP/DP), Behavioral Health (BH) and Chronic Care (CC). The Director's Three Initiative is linked together in their aim to reduce health disparities and improve the health and wellness among the AI/AN populations through a coordinated and systematic approach to enhance health promotion, and chronic disease and mental health prevention methods at the local, regional, and national levels. To provide the product/service to IHS, Tribal, and Urban (I/T/U) programs, the Director's Three Initiative work together to develop a centralized program database of Best/Promising Practices (BPP). The purpose of this collection is to develop a database of BPP to be published on the IHS.gov Web site which will be a resource for program evaluation and for modeling examples of HP/DP, BH, and CC projects occurring in AI/AN communities. This is a request that OMB approves, under the Paperwork Reduction Act, an IHS information collection initiative to promote submission of ``Best and Promising Practices and Local Efforts'' among the I/T/U. All information submitted is on a voluntary basis; no legal basis exists for collection of this information. The information collected will enable the Director's Three Initiative program to: (a) Identify evidence based approaches to prevention programs among the I/T/U when no system is currently in place; and (b) Allow the program managers to review BPPPLE occurring among the I/T/U when considering program planning for their community. Affected Public: Individuals. Type of Respondents: I/T/U organizations program staff. The table below provides: Types of data collection instruments, Number of respondents, Responses per respondent, Average burden hour per response, and Total annual burden hour(s). Estimated Burden Hours

The Health Resources and Services Administration (HRSA) is requesting nominations to fill ten upcoming vacancies on the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL).