Department of Health and Human Services February 5, 2013 – Federal Register Recent Federal Regulation Documents

Request for Comment: Input on Recommendations from the Council of Councils Working Group on Use of Chimpanzees in NIH-Supported Research
Document Number: 2013-02507
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) Council of Councils received and adopted the recommendations and Report of the NIH Council of Councils Working Group on the Use of Chimpanzees in NIH-Supported Research on January 22, 2013. The report is posted on the NIH Web site at http://dpcpsi.nih.gov/council/working_group_message.aspx. The agency will consider the recommendations contained in the report as the agency formulates policy. The NIH also announces the opening of a Request for Comment (RFC) period to collect input on the recommendations from interested parties. Comments will be accepted until Saturday, March 23, 2013, via the comment database at http:// grants.nih.gov/grants/rfi/rfi.cfm?ID=31. In the interim, NIH will continue to apply its policy on Research Involving Chimpanzees (see NOT-OD-12-025; http://grants.nih.gov/grants/guide/notice-files/NOT-OD- 12-025.html.)
Proposed Collection; Comment Request: Women's Health Initiative Observational Study
Document Number: 2013-02505
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: The Women's Health Initiative (WHI) Observational Study. Type of Information Collection Request: Revision OMB 0925-0414. Need and Use of Information Collection: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women. Frequency of Response: Annually. Affected Public: Individuals or households and health care providers. Type of Respondents: Study participants, next-of-kin, and physician's office staff. The annual reporting burden is as follows:
Submission for OMB Review; Comment Request (30-Day FRN): The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI)
Document Number: 2013-02503
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on December 6, 2012 (Vol. 77, p. 72871) and allowed 60 days for public comment. No public comments have been received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Attention: NIH Desk Officer, Office of Management and Budget, at OIRA_ submission@omb.eop.gov or by fax to 202-395-6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Jane Hoppin, Sc.D., Epidemiology Branch, National Institute of Environmental Health Sciences, NIH, 111 T.W. Alexander Drive, PO Box 12233, MD A3-05, Research Triangle Park, NC 27709, or call non-toll-free number 919-541- 7622, or email your request, including your address to: hoppin1@niehs.nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Proposed Collection: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture, 0925-0406, Expiration Date 5/31/2013REVISIONNational Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). Need and Use of Information Collection: The purpose of this information collection is to continue and complete updating the occupational and environmental exposure information as well as medical history information for licensed pesticide applicators and their spouses enrolled in the Agricultural Health Study. This represents a request to complete phase IV (2013-2015) of the study and to continue and complete the buccal cell collection and the Study of Biomarkers of Exposures and Effects in Agriculture (BEEA). The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environment. The phase IV follow up data will be collected by using one of three methods of the cohort member's choosing: Self-administered computer assisted Web survey (CAWI); self-administered paper-and-pen (Paper/pen); or an interviewer administered computer assisted telephone interview (CATI). Proxy interviews for those cohort members unable to complete the follow up will be completed by using one of the three methods as well. Secondary objectives include evaluating biological markers that may be associated with agricultural exposures and risk of certain types of cancer. Questionnaire data will be collected by using computer assisted telephone interview (CATI) and in-person interview (CAPI) systems for telephone screeners and home visit interviews, respectively. Some respondents will also be asked to participate in the collection of biospecimens including blood, urine, and buccal cells (loose cells from the respondent's mouth). The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 10,465.
Establishment of the 2015 Dietary Guidelines Advisory Committee
Document Number: 2013-02502
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services announces establishment of the 2015 Dietary Guidelines Advisory Committee (hereafter referred to as the Committee or 2015 DGAC). The 2015 DGAC is an expert advisory committee that has been established to assist the Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) perform a single, time-limited task.
Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption
Document Number: 2013-02497
Type: Rule
Date: 2013-02-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled ``Criteria Used to Order Administrative Detention of Food for Human or Animal Consumption'' that published in the Federal Register on May 5, 2011, (the 2011 IFR). This final rule affirms the IFR's change to the criteria for ordering administrative detention of human or animal food as required by the FDA Food Safety Modernization Act (FSMA). Under the new criteria, FDA can order an administrative detention if there is reason to believe that an article of food is adulterated or misbranded. This final rule does not make any changes to the regulatory requirements established by the IFR. The final regulation also responds to comments submitted in response to the request for comments in the IFR.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-02490
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-02488
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Findings of Research Misconduct
Document Number: 2013-02487
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Bryan William Doreian, Ph.D., Case Western Reserve University: Based on the admission of the Respondent, ORI found that Dr. Bryan William Doreian, former postdoctoral fellow, Department of Dermatology, Case Western Reserve University (CWRU), engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grant T32 HL07887 and National Institute of Neurological Disorders and Stroke (NINDS), NIH, grant R01 NS052123. ORI found that the Respondent engaged in research misconduct by falsifying data that were included in: Doreian, B.W. ``Molecular Regulation of the Exocytic Mode in Adrenal Chromaffin Cells.'' Submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy, August 2009; hereafter referred to as the ``Dissertation.'' Doreian, B.W., Fulop, T.G., Meklemburg, R.L., Smith, C.B. ``Cortical F-actin, the exocytic mode, and neuropeptide release in mouse chromaffin cells is regulated by myristoylated alanine-rich C- kinase substrate and myosin II.'' Mol Biol Cell. 20(13):3142-54, 2009 Jul; hereafter referred to as the ``Mol Biol Cell paper.'' Doreian, B.W., Rosenjack, J., Galle, P.S., Hansen, M.B., Cathcart, M.K., Silverstein, R.L., McCormick, T.S., Cooper, K.D., Lu, K.Q. ``Hyper-inflammation and tissue destruction mediated by PPAR- [gamma] activation of macrophages in IL-6 deficiency.'' Manuscript prepared for submission to Nature Medicine; hereafter referred to as the ``Nature Medicine manuscript.'' As a result of the Respondent's admission, the Respondent will request that the following paper be retracted: Mol Biol Cell. 20(13):3142-54, 2009 Jul. ORI finds that Respondent falsified numerical values in the Mol Biol Cell paper, the submitted Nature Medicine manuscript, and the Dissertation by altering the number of samples or the experimental results to improve the statistical results. Specifically, ORI finds that Respondent: 1. Falsified the quantification of immunofluorescence for the ratio of phosphorylated to unphosphorylated MARCKS protein in response to different stimuli in Figure 2 of the Mol Biol Cell paper and in Figure 12 of the Dissertation by falsifying the sample number as n=15. 2. Falsified the quantification of immunofluorescence for filamentous actin in response to different stimuli in Figure 3 of the Mol Biol Cell paper and in Figure 13 of the Dissertation by falsifying the sample number as n=15. 3. Falsified the quantification for the effect of blebbistatin on catecholamine release as determined by patch clamp analysis in Figure 22 of the Dissertation by stating that 14 cells had been assayed when only 8 cells had been assayed. 4. Falsified the Pearson's cross-correlation analysis in Figure 7 of the Mol Biol Cell paper and in Figure 25 of the Dissertation, used to calculate the degree of spatial correlation between pan-chromogranin A/B (CgA/B) and the endosomal membrane, by stating that 20 or more cells had been tested for each condition when only 9-18 cells had been tested for each condition. 5. Falsified RT-PCR values for iNOS and TNF-alpha expression recorded on spreadsheets and presented in Figures 5e and 5f of the Nature Medicine manuscript showing the effect of hyper-inflammatory macrophage generation on tissue destruction, by falsifying the numeric values to fit the hypothesis of the manuscript. 6. Falsified ELISA graphs for the concentration of TNF-[alpha] in the aAB IL-6 mice and their controls in Figure 6j of the Nature Medicine manuscript showing the effect of rosiglitazone treatment in the mice, by multiplying the experimental values by 100 to match the magnitude of the values presented in Figures 21, 6h, and 6i of the Nature Medicine manuscript. 7. Falsified the RT-PCR results presented in the Nature Medicine manuscript for quantification of iNOS and TNF-[alpha] RNA expression by claiming that the results represent the rmean of three identical experiments when the three experiments were normalized differently to yield the desired result. Specifically, false results were presented for peritoneal macrophages treated in vivo with rosiglitazone and/or inhibitors of PPAR[gamma] signaling Figures 1g, 1h, and 1i, and for iNOS RNA expresssion in IL6-/- macrophages treated in vitro with either SOCS3 antisense oligonucleotides in Figure 2g or the STAT3 decoy in Figure 2j. Dr. Doreian has entered into a Voluntary Settlement Agreement and has voluntarily agreed for a period of three (3) years, beginning on January 15, 2013: (1) To have his research supervised; Respondent agreed that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which his participation is proposed and prior to his participation in any capacity on PHS- supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of his research contribution; he agreed that he shall not participate 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; (2) That any institution employing him 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; (3) To exclude himself voluntarily 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 (4) To request that the following paper be retracted: Mol Biol Cell. 20(13):3142-54, 2009 Jul.
National Institutes of Health
Document Number: 2013-02480
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register in Volume 77, No. 199/Monday, October 15, 2012, pages 62518- 62519, and allowed 60-days for public comment. No comments have been received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Recipient Epidemiology and Donor Evaluation Study-III (REDS-III). Type of Information Collection Request: New. Need and Use of Information Collection: The objective of the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program is to ensure safe and effective blood banking and transfusion medicine practices through a comprehensive, multifaceted strategy involving basic, translational, and clinical research to improve the benefits of transfusion while reducing its risks. The conduct of epidemiologic, survey, and laboratory studies is the cornerstone of REDS-III and its predecessors, the REDS and REDS-II programs. Over the past 20 years, the National Heart, Lung, and Blood Institute (NHLBI) REDS programs have proven to be the premier research programs in blood collection and transfusion safety in the United States. Successive renditions of the REDS programs have built upon the many successes that this research network has realized over the years while being responsive to changing research and clinical needs, and adapting to emerging priorities. Research findings have served to improve the screening of donors and collected blood products, blood banking practices, diagnoses, and the basic science principles of transfusion medicine. While significant progress has been made, transfusion therapya very commonly used therapy affecting about six million recipients annually in the U.S.remains one of the least understood medical procedures. REDS-II conducted studies of blood donor health but much more needs to be learned, including how donor genetic or environmental factors may affect the quality of collected blood components and influence non-infectious transfusion complications in recipients. Additionally, there is always the potential that a new, emerging or re- emerging infection may pose a threat to the safety of the U.S. blood supply. Much of the success of the REDS programs was due to their ability to respond in a timely fashion to potential blood safety threats such as West Nile Virus (WNV) in 2002 or Xenotropic Murine Leukemia Virus Related Virus (XMRV) in 2009. Globally, the threat of HIV and other blood-borne infections to blood safety remains real and has to be closely monitored. Therefore, continuing collection of new scientific evidence through REDS-III is both critical to public health in the U.S. and to countries struggling with the HIV epidemic where blood safety and availability are major concerns. Additionally, the research areas encompassed in REDS-III have been and continue to be hypothesis generating, leading to the development of new basic and translational research projects with implications well beyond the fields of blood banking and transfusion medicine. REDS-III has also been charged with the tasks of education and training and integration of these components in a transfusion medicine research network. With this submission, the REDS-III Study seeks approval from OMB to develop research studies with data collection activities using focus groups, cognitive interviews, questionnaires and/or qualitative interviews following all required informed consent procedures for respondents and parents/caregivers as appropriate. With this generic clearance, study investigators will be able to use the OMB-approved data collection methods where appropriate to plan and implement time sensitive studies. Such studies that fall within the overall scope of this submission will be subjected to expedited review and approval by OMB before their implementation. Additionally, studies are reviewed by an NHLBI Observational Study Monitoring Board (OSMB) and by all relevant IRBs. Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Males and females 16 years old or older. The annual reporting burden is as follows: Estimated Number of Respondents: 6,882; Estimated Number of Responses per Respondent: Focus Groups: 1 per respondent; Cognitive Interviews: 2 per respondent; Respondent Surveys: 3 per respondent. Average Burden of Hours per Response: Focus Groups: 1.5 hours per respondent; Cognitive Interviews: 1 hour per respondent; Respondent Surveys: 20 minutes per respondent Estimated Total Annual Burden Hours Requested: 7,532. The annualized total costs to all respondents are $66,288. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.
Extension of a Currently Approved Information Collection; Comment Request
Document Number: 2013-02405
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2013-02389
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2013-02388
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-02387
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-02386
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-02384
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2013-02295
Type: Notice
Date: 2013-02-05
Agency: Department of Health and Human Services, Administration for Children and Families