Department of Health and Human Services December 2012 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection: Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
New Animal Drugs; Enrofloxacin; Melengestrol; Meloxicam; Pradofloxacin; Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Weldon Spring Plant in Weldon Spring, Missouri, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. Sec. 7384q. On December 7, 2012, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Los Alamos National Laboratory (LANL) in Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Mound Plant in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Shuang-Qing Zhang, Ph.D., Texas Tech University Health Sciences Center: Based on the report of an investigation conducted by the Texas Tech University Health Sciences Center (TTUHSC) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Shuang- Qing Zhang, former Postdoctoral Researcher, Department of Pharmaceutical Sciences, TTUHSC, engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM069869. ORI found that Respondent engaged in research misconduct by the falsification and fabrication of plagiarized data that were included in the publication: Zhang, S.Q. & Mehavr, R. ``Determination of dextra- methylprednisolone conjugate with glycine linker in rat plasma and liver by high-performance liquid chromatography and its application in pharmacokinetics.'' Biomed. Chromatogr. 24(4):351-357, 2010 (hereafter the ``BC 2010 article''). Specifically, ORI found that the Respondent: Falsified Figures 2(c) and 3(c) of the BC 2010 article by misrepresenting HPLC data that he had plagiarized, originally generated prior to the Respondent's arrival in the laboratory by a former postdoctoral researcher; in Figure 2(c), the Respondent claimed that the HPLC chromatogram was of a ``plasma sample obtained 12 h after intravenous injection of DMP to rats at a single dose of 5 mg/kg,'' while the actual chromatogram was of a calibration test of 1 [mu]g/ml of DMP added to rat plasma, and similarly in Figure 3(c), the Respondent claimed that the HPLC chromatogram was of a ``liver homogenate obtained 3 h after intravenous dose of DMP at a dose of 5 mg/kg,'' while the actual chromatogram was of a calibration test of 2 [mu]g/ml DMP added to rat liver homogenate. Falsified and fabricated Figure 4 of the BC 2010 article; in the top panel, the Respondent reported the measurement of DMP concentrations in plasma samples of three rats after a single injection of 5 mg/kg DMP while the actual data that he had plagiarized, originally generated prior to the Respondent's arrival in the laboratory by a former postdoctoral researcher, was from a single rat. In the bottom panel, the Respondent reported the measurement of DMP concentrations in liver samples obtained from three rats at 1, 30, 90, 180, 300, and 720 minutes after a single injection of 5 mg/kg DMP, requiring a total of 18 rats, while the actual data that he had plagiarized, originally generated prior to the Respondent's arrival in the laboratory by a former postdoctoral researcher, was from plasma samples from a single rat, and the error bars for both panels were fabricated. Dr. Zhang has entered into a Voluntary Settlement Agreement and has voluntarily agreed: (1) To have his research supervised for a period of three (3) years; Respondent voluntarily agrees that within sixty (60) days of the effective date of the Agreement, 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 research to ORI for approval; Respondent agrees that he will not participate in any PHS-supported research after sixty (60) days from the effective date of the Agreement until an appropriate supervision plan is submitted to ORI; the supervision plan must be designed to ensure the scientific integrity of the Respondent's research contribution; and (2) 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 for a period of three (3) years, beginning on December 4, 2012.
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from the Oak Ridge National Laboratory (X-10) in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC:
Determination Concerning a Petition to Add a Class of Employees to the Special Exposure Cohort
HHS gives notice of a determination concerning a petition to add a class of employees from the Mound Plant in Miamisburg, Ohio, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On December 7, 2012, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:
Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice of a decision to designate a class of employees from Nuclear Metals, Inc. (or a subsequent owner) in West Concord, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, the Secretary of HHS designated the following class of employees as an addition to the SEC: All Atomic Weapons Employees who worked at the facility owned by Nuclear Metals, Inc. (or a subsequent owner) in West Concord, Massachusetts, during the period from October 29, 1958, through December 31, 1979, for a number of work days aggregating at least 250 work days, occurring either solely under this employment, or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Martin Biosse-Duplan, D.D.S., Ph.D., Harvard School of Dental Medicine: Based on the report of an investigation conducted by the Harvard School of Medicine (HSM) and Harvard School of Dental Medicine (HSDM), the admission of the Respondent, and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Martin Biosse-Duplan, former Research Fellow, Department of Oral Medicine, Infection, and Immunity, HSDM, engaged in research misconduct in research supported by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), grant R01 AR054450. ORI found that the Respondent engaged in research misconduct involving one (1) laboratory presentation and two (2) published abstracts: Boisse-Duplan, M., Stephens, S., Lai, F.P.L., Oelkers, M., Kitamura, D., Rottner, K., Horne, W., & Baron, R. ``The Association Between the Microtubule Plus End Protein EB1 and Cortactin Controls Podosomes and Bone Resorption.'' J Bone Min Res 26:Supl.1, pS215. Boisse-Duplan, M., Stephens, S., Lai, F.P.L., Oelkers, M., Rottner, K., Horne, W., & Baron, R. ``In Osteoclasts, Dynamic Microtubules and their Associated Protein EB1 Control Podosomes and Bone Resorption through Cortactin.'' Bone 48:Suppl. 2, pS97. As a result of HSM's and HSDM's investigation, the data were not presented at the meetings and the experiments reported in the abstracts are being redone. Specifically, ORI finds that Respondent: Falsified Powerpoint slides and spreadsheets for histomorphometric and microCT results by using the values of HS1 knockout (KO) mice and their controls to represent the CathepsinK cre- Cortactin KO mice and their controls; Dr. Biosse-Duplan also switched two sets of numbers between the HS1 KO mice and their controls to falsely demonstrate a difference in bone density when there was none. The numerical data were presented at a lab meeting, and false text was included in two submitted meeting abstracts published in Bone 48:Suppl 2, pS97 and J Bone and Mineral Research 25:Suppl 1, pS215. Both the Respondent and HHS want to conclude this matter without further expenditure of time or other resources and have entered into a Voluntary Settlement Agreement (Agreement) to resolve this matter. Dr. Boisse-Duplan has entered into a Voluntary Settlement Agreement and has voluntarily agreed: (1) That if within two (2) years from the effective date of the Agreement Respondent does receive or apply for PHS support, Respondent agrees to have his research supervised for a period of two (2) years beginning on the date of his employment in a research position in which he receives or applies for PHS support and to notify his employer(s)/ institution(s) of the terms of this supervision; Respondent agrees that prior to the submission of an application for PHS support for a research project on which the Respondent's participation is proposed and prior to 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; 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; (2) That if within two (2) years from the effective date of the Agreement, Respondent does receive or apply for PHS support, Respondent agrees 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; and (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 for a period of two (2) years, beginning on December 4, 2012.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary, Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Solicitation of New Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extending the use of the approved information collection assigned OMB control number 0990-0308, which expires on June 30, 2013. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Draft Environmental Assessment and Preliminary Finding of No Significant Impact Concerning a Genetically Engineered Atlantic Salmon; Availability
The Food and Drug Administration (FDA, the Agency) is announcing the availability for public comment of the Agency's draft environmental assessment (EA) of the proposed conditions of use specified in materials submitted by AquaBounty Technologies, Inc., in support of a new animal drug application (NADA) concerning a genetically engineered (GE) Atlantic salmon. Also available for comment is the Agency's preliminary finding of no significant impact (FONSI) for those specific conditions of use.
Public Workshop on Minimal Residual Disease; Public Workshop
The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia (CLL). Our objective for the workshop is to provide a venue for an in- depth discussion of potential surrogate endpoints for trials intended to support the approval of new drugs or biologics for the treatment of CLL. Participants in the workshop will examine the advantages and disadvantages of MRD as a surrogate endpoint for approval, identify the preferred technology platform and performance characteristics for the assay of this biomarker, and discuss any issues regarding methodological standardization for the biomarker. The primary focus will be on the biomarkers that are ready for incorporation into clinical trials and the technical and regulatory challenges for use of these markers.
Public Workshop on Minimal Residual Disease; Public Workshop
The Food and Drug Administration (FDA), in cosponsorship with the American Society of Clinical Oncology, is announcing a public workshop that will provide a forum for discussion of extending the qualification of minimal residual disease (MRD) detection as a prognostic biomarker to an efficacy/response biomarker in evaluating new drugs for the treatment of acute myeloid leukemia (AML). Our objective is for the workshop to provide a venue for an in-depth discussion of potential endpoints for trials intended to support the approval of new drugs or biologics for treatment of AML. Participants in the workshop will examine if any currently used biomarker can be used as a surrogate endpoint, identify the preferred technology platform and performance characteristics for the assay of the biomarker, discuss any issues regarding ongoing deficiencies in methodological standardization for the biomarker, and determine the need for additional FDA-approved in-vitro diagnostics for AML drug development. The primary focus will be on the biomarkers that are or will soon be ready for incorporation into clinical trials, and the technical and regulatory challenges for use of these markers.
Public Meeting of the Presidential Commission for the Study of Bioethical Issues
The Presidential Commission for the Study of Bioethical Issues (the Commission) will conduct its twelfth meeting in January. At this meeting, the Commission will continue discussing topics related to the ethical issues associated with the development of medical countermeasures for children.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising
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.
Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Tuesday, November 20, 2012 (77 FR 69632). The document announced the availability of a draft guidance entitled ``Electronic Source Data in Clinical Investigations.'' The document was published with an incorrect date in the DATES section. This document corrects that error.
Proposed Collection; Comment Request; Pediatric Palliative Care Campaign Pilot Survey
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 Institute of Nursing Research (NINR), 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. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact Ms. Adrienne Burroughs, Health Communications Specialist, Office of Communications and Public Liaison, NINR, NIH, Building 31, Room 5B10, 31 Center Drive, Bethesda, MD 20892, or call non-toll-free number (301) 496-0256, or Email your request, including your address to: adrienne.burroughs@nih.gov. Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication. Proposed Collection: Pediatric Palliative Care Campaign Pilot Survey-0925-New-National Institute of Nursing Research (NINR), National Institutes of Health (NIH). Need and Use of Information Collection: NINR developed a Pediatric Palliative Care Campaign to address the communications challenges faced by health care providers who recommend and provide palliative care to pediatric populations. NINR is launching this effort to increase the use of palliative care for children living with serious illness or life-limiting conditions. The Pediatric Palliative Care Campaign Pilot Survey will assess the information and materials being disseminated as part of the Pediatric Palliative Care Campaign pilot. Survey findings will help (1) determine if the pilot campaign is effective, relevant, and useful to health care providers who recommend and provide palliative care to pediatric populations; (2) to better understand current perceptions, challenges, and information needs of health care providers when it comes to discussing pediatric palliative care so that information and materials can be refined; and (3) examine how effective the campaign pilot materials are in starting and continuing a pediatric palliative care conversation and addressing the communications needs of health care providers around this topic. This assessment will deliver strategic and actionable guidance for refining the campaign materials so that they can be used by a wider audience of health care providers. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 26.
Findings of Research Misconduct
Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Terry S. Elton, Ph.D., The Ohio State University: Based on the reports of two investigations conducted by The Ohio State University (OSU) and additional analysis conducted by ORI in its oversight review, ORI found that Dr. Terry S. Elton, Professor, College of Pharmacy and Davis Heart and Lung Research Institute, OSU, engaged in research misconduct in research supported by National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants R01 HL048848, R01 HL084498, and P01 HL70294, National Institute of Child Health and Human Development (NICHD), NIH, grant R21 HD058997, National Institute on Aging (NIA), NIH, grant R01 AG021912, National Institute of Allergy and Infectious Diseases (NIAID), NIH, grant R01 AI39963, and National Eye Institute (NEI), NIH, grant R01 ES012241. ORI found that the Respondent engaged in research misconduct by falsifying and/or fabricating data that were included in 1 R21 HD058997-01, 1 R21 HD058997-01A1, 1 R21 HD058997-01A2, 1 RC1 HL100298- 01, and in: 1. Kuhn, D.E., Nuovo, G.J., Terry, A.V. Jr., Martin, M.M., Malana, G.E., Sansom, SE., Pleister, A.P., Beck, W.D., Head, E., Feldman, D.S., & Elton, T.S. ``Chromosome 21-derived microRNAs provide an etiological basis for aberrant protein expression in human Down syndrome brains.'' J Biol Chem 285(2):1529-43, 2010 Jan 8. 2. Kuhn, D.E., Nuovo, G.J., Martin, M.M., Malana, G.E., Pleister, A.P., Jiang, J., Schmittgen, T.D., Terry, A.V. Jr., Gardiner, K., Head, E., Feldman, D.S., & Elton, T.S. ``Human chromosome 21-derived miRNAs are overexpressed in Down syndrome brains and hearts.'' Biochem Biophys Res Commun 370(3):473-7, 2008 Jun 6. 3. Martin, M.M., Buckenberger, J.A., Jiang, J., Malana, G.E., Knoell, D.L., Feldman, D.S., & Elton, T.S. ``TGF[szlig]1 stimulates human AT1 receptor expression in lung fibroblasts by cross talk between the Smad, p38 MAPK, JNK, and PI3K signaling pathways.'' Am. J. Physiol. Lung Cell. Mol. Physiol. 293(3):L790-9, 2007 Sept. (Retracted: Am. J. Physiol. Lung Cell. Mol. Physiol. 302(7):L719, 2012 Apr.) 4. Martin, M.M., Buckenberger, J.A., Jiang, J., Malana, G.E., Nuovo, G.J., Chotani, M., Feldman, D.S., Schmittgen, T.D., & Elton, T.S. ``The human angiotensin II type 1 receptor +1166 A/C polymorphism attenuates microRNA-155 binding.'' J Biol Chem 282(33):24262-9, 2007, Aug 17. 5. Martin, M.M., Buckenberger, J.A., Knoell, D.L., Strauch, A.R., & Elton, T.S. ``TGF-beta(1) regulation of human AT1 receptor mRNA splice variants harboring exon 2.'' Mol Cell Endocrinol 249(1-2):21-31, 2006 Apr 25. 6. Duffy, A.A., Martin, M.M., & Elton, T.S. ``Transcriptional regulation of the AT1 receptor gene in immortalized human trophoblast cells.'' Biochim. Biophys. Acta. 1680(3):158-70, 2004 Nov 5. As a result of its investigation, OSU has recommended that all of the above publications be retracted. Specifically, ORI finds that Respondent: Falsified and/or fabricated Western blots in an NIH grant application in three submissions of the same grant application:
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