Findings of Research Misconduct, 38316-38317 [2018-16693]

Download as PDF 38316 Federal Register / Vol. 83, No. 151 / Monday, August 6, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES months or more exposure over a lifetime. Because of the duration of use, the nonclinical assessment for marketing approval should include general toxicity studies, developmental and reproductive toxicity studies, an assessment of carcinogenic potential, and supporting toxicokinetic and pharmacokinetic studies. FDA is aware of the serious risk associated with smoking and is committed to facilitating the development of therapies to support smoking cessation efforts. This guidance focuses on novel components of the drug product formulation, heatgenerated products, and impurities that are generally not well characterized. Orally inhaled nicotine-containing tobacco products, including electronic nicotine delivery systems currently marketed in the United States, have already been associated with toxicity concerns (Refs 1–4). An adequate nonclinical assessment, as described in this guidance, can address the potential toxicity of chemicals from orally inhaled nicotine-containing drug products. As noted in the guidance, sponsors can use an alternative approach if that approach provides adequate safety information. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on nonclinical testing of orally inhaled nicotine-containing drug products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR part 312 have been approved under OMB control number 0910–0014. The collections of information resulting from special protocol assessments have been approved under OMB control number 0910–0470. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. VerDate Sep<11>2014 17:36 Aug 03, 2018 Jkt 244001 IV. References The following reference marked with an asterisk (*) is on display at the Dockets Management Staff (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it also is available electronically at https:// www.regulations.gov. References without asterisks are not on display because they have copyright restriction, or they are available as published articles and books. Please contact the person identified in the FOR FURTHER INFORMATION CONTACT section to schedule a date to inspect references without asterisks. 1. Madsen, L.R., N.H. Vinther Krarup, T.K. Bergmann, et al., 2016, ‘‘A Cancer That Went Up in Smoke: Pulmonary Reaction to E-Cigarettes Imitating Metastatic Cancer,’’ Chest, 149(3):e65–67. 2. Ghosh, A., R.C. Coakley, T. Mascenik, et al., 2018, ‘‘Chronic E-Cigarette Exposure Alters the Human Bronchial Epithelial Proteome,’’ American Journal of Respiratory and Critical Care Medicine, epub ahead of print February 26, 2018, doi: 10.1164/rccm.201710–2033OC. * 3. Olmedo, P., W. Goessler, S. Tanda, et al., 2018, ‘‘Metal Concentrations in ECigarette Liquid and Aerosol Samples: The Contribution of Metallic Coils,’’ Environmental Health Perspectives, 126(2): doi: 10.1289/EHP2175. 4. Rubinstein, M.L., K. Delucchi, N.L. Benowitz, and D.E. Ramo, 2018, ‘‘Adolescent Exposure to Toxic Volatile Organic Chemicals From E-Cigarettes,’’ Pediatrics, epub ahead of print March 5, 2018, doi: 10.1542/peds.2017–3557. Dated: July 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–16726 Filed 8–3–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. Notice. AGENCY: ACTION: Notice is hereby given that on July 13, 2018, the U.S. Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on an Administrative Law Judge’s findings of research misconduct against Christian Kreipke, Ph.D., former Research Associate Professor, Wayne State University. Dr. Kreipke engaged in research misconduct in research supported by National Institute of SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grants R01 NS039860 and R01 NS064976–01A2. The administrative actions, including five (5) years of debarment, were implemented beginning on July 13, 2018, and are detailed below. FOR FURTHER INFORMATION CONTACT: Wanda K. Jones, Dr.P.H., Interim Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8200. SUPPLEMENTARY INFORMATION: Christian Kreipke, Ph.D., Wayne State University: ORI issued a charge letter enumerating findings of research misconduct and proposing HHS administrative actions. Dr. Kreipke (‘‘Respondent’’) subsequently requested a hearing before an Administrative Law Judge (ALJ) of the Departmental Appeals Board to dispute these findings. A hearing before the ALJ was held on July 10–12, 2017. On May 31, 2018, the ALJ issued his recommended decision, finding that Respondent recklessly caused or permitted twenty-three (23) instances of research misconduct in his three (3) grant applications, two (2) articles on which he was the first listed author, and two (2) posters on which he was the first listed author. The ALJ held that appropriate administrative actions included a five-year debarment from any contracting or subcontracting with any agency of the United States and from eligibility for or involvement in nonprocurement programs of the United States referred to as ‘‘covered transactions.’’ 2 CFR parts 180 and 376. The ALJ held it was an appropriate administrative action to also impose a five-year prohibition from serving in any capacity to the U.S. Public Health Service (PHS), including but not limited to, service on any PHS advisory committee, board, or peer review committee, or as a consultant. The ALJ noted that ORI also had proposed that the publisher of certain articles be notified of the need to retract those articles and that retraction had already occurred by the time of his recommended decision. Under the regulation, the ALJ’s recommended decision went to the Assistant Secretary for Health, who did not modify it and forwarded it to the HHS Debarring Official, who is the deciding official for the debarment. The ALJ decision constituted the findings of fact to the HHS Debarring Official in accordance with 2 CFR 180.845(c). On July 13, 2018, the HHS Debarring Official issued a final notice of debarment to begin on July 13, 2018, and end on July 12, 2023. E:\FR\FM\06AUN1.SGM 06AUN1 sradovich on DSK3GMQ082PROD with NOTICES Federal Register / Vol. 83, No. 151 / Monday, August 6, 2018 / Notices Respondent’s grant applications, articles, and posters in question examined the differential effects of endothelin receptor antagonists on traumatic brain injury-induced hypoperfusion of cerebral blood flow, neuronal cell injury, and cognition in rat animal models. Respondent recklessly included falsely described images in the following grant applications: • R01 NS064976–01A1 submitted to NINDS, NIH (unfunded) • R01 NS064976–01A2 submitted to NINDS, NIH (funded) • R01 NS065824–01 submitted to NINDS, NIH (unfunded) Respondent recklessly included falsely described images in the following publications and posters: • ‘‘Differential effects of endothelin receptor A and B antagonism on cerebral hypoperfusion following traumatic brain injury.’’ Neurological Research 32(2):209–14, 2010 Mar (‘‘NR2010’’). Retracted in Neurological Research 39(5):472, 2017 May. • ‘‘Clazosentan, a novel endothelin A antagonist, improves cerebral blood flow and behavior after traumatic brain injury.’’ Neurological Research 33(2):208–13, 2011 Mar (‘‘NR2011–1’’). Retracted in Neurological Research 39(5):472, 2017 May. • 2009 poster for a Department of Veterans Affairs (VA) presentation: ‘‘Using endothelin-A antagonists to ameliorate hypoperfusion and cognitive deficits following brain trauma: towards a clinical trial’’ (‘‘VA2009’’). • 2010 poster for a VA presentation: ‘‘Endothelin-1 receptor A antagonists improve neurologic and cognitive outcome following TBI’’ (‘‘VA2010’’). The following findings of research misconduct were proven by a preponderance of the evidence. Respondent recklessly included: • falsely described Fluoro-Jade stained images of rat brain cells in: —Figure 8 (left panel) in R01 NS064976–01A1 —Figure 8B (left panel) in R01 NS064976–01A2 —Figures 4A–F in R01 NS065824–01 —Figure 3 (right and left panels) in NR2011–1 —Figure 5C in NR2010 —Figure 3 (panel 3) and Figure 6 (right and left panels) in VA2009 —Figure 3 (panel 3) and Figure 6 (right and left panels) in VA2010 • falsely described systolic blood pressure curves in Figures 4A and 4B in NR2010 • falsely described cerebral blood flow graphs in: —Figure 5 (left panel) in R01 VerDate Sep<11>2014 17:36 Aug 03, 2018 Jkt 244001 NS064976–01A1 —Figure 5 (left panel) in R01 NS064976–01A2 —Figure 3A in NR2010 —Figure 5 in VA2009 —Figure 5 in VA2010 • falsely described Western blot images in one of the following three grant applications (because at least one of the three must be false): Figure 1 (me+TBI panel for VEGF) in R01 NS065824–01, Figure 2B in R01 NS064976–01A1, and Figure 2B in R01 NS064976–01A2 • falsely described Western blot images in: —Figure 2A in R01 NS064976–01A1 —Figure 2A in R01 NS064976–01A2 • a falsely described image of lectin labeled rat brain section in Figure 2C in R01 NS065824–01 Thus, the research misconduct findings set forth above became effective, and the following administrative actions have been implemented for a period of five (5) years, beginning on July 13, 2018: (1) Dr. Kreipke is debarred 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) of Office of Management and Budget (OMB) Guidelines to Agencies on Governmentwide Debarment and Suspension (2 CFR part 180); and (2) Dr. Kreipke is prohibited 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. Wanda K. Jones, Interim Director, Office of Research Integrity. [FR Doc. 2018–16693 Filed 8–3–18; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket Number USCG–2018–0193] Polar Icebreaker Program; Preparation of Environmental Impact Statement Coast Guard, DHS. Notice of Availability and request for comments. AGENCY: ACTION: The U.S. Coast Guard, as lead agency, announces the availability of a draft Programmatic Environmental Impact Statement (EIS) in accordance SUMMARY: PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 38317 with the National Environmental Policy Act (NEPA) for the Polar Icebreaker Program’s design and build of up to six polar icebreakers. The U.S. Coast Guard requests public comments on the draft EIS. DATES: Comments must be submitted to the online docket via https:// www.regulations.gov on or before September 20, 2018. ADDRESSES: You may submit comments identified by docket number USCG– 2018–0193 using the Federal portal at https://www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. If you have questions about this notice of intent, email Mr. Ahmed Majumder, Deputy Program Manager, Polar Icebreaker Program, U.S. Coast Guard; email PIBEnvironment@uscg.mil. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Table of Abbreviations CFR Code of Federal Regulations CGC Coast Guard Cutter EIS Environmental Impact Statement FR Federal Register NEPA National Environmental Policy Act PIBs Polar Icebreakers U.S.C. United States Code II. Background and Purpose The U.S. Coast Guard’s current fleet of polar icebreakers (PIBs) consists of two heavy icebreakers, Coast Guard Cutter (CGC) POLAR STAR and CGC POLAR SEA, and one medium icebreaker, CGC HEALY. The U.S. Coast Guard’s heavy icebreakers have both exceeded their designed 30 year service life. CGC POLAR STAR was commissioned in 1976 and CGC POLAR SEA in 1978. CGC POLAR STAR began reactivation in 2010 and completed a service life extension in 2013 to allow CGC POLAR STAR to operate for an additional seven to ten years. CGC POLAR SEA has remained out of service since 2010 and is not expected to be reactivated. The current PIB program acquisition strategy is approved to construct up to three heavy PIBs and may (at a future date) potentially expand to include up to three medium icebreakers, with planned service design lives of 30 years each. The first of these new PIBs is expected to delivered in 2023. Because the first new PIB would not be operational in the Polar Regions until at least 2023, new information may become available after the completion of this EIS. In that case, supplemental NEPA documentation may, as appropriate, be prepared in E:\FR\FM\06AUN1.SGM 06AUN1

Agencies

[Federal Register Volume 83, Number 151 (Monday, August 6, 2018)]
[Notices]
[Pages 38316-38317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16693]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Findings of Research Misconduct

AGENCY: Office of the Secretary, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: Notice is hereby given that on July 13, 2018, the U.S. 
Department of Health and Human Services (HHS) Debarring Official, on 
behalf of the Secretary of HHS, issued a final notice of debarment 
based on an Administrative Law Judge's findings of research misconduct 
against Christian Kreipke, Ph.D., former Research Associate Professor, 
Wayne State University. Dr. Kreipke engaged in research misconduct in 
research supported by National Institute of Neurological Disorders and 
Stroke (NINDS), National Institutes of Health (NIH), grants R01 
NS039860 and R01 NS064976-01A2. The administrative actions, including 
five (5) years of debarment, were implemented beginning on July 13, 
2018, and are detailed below.

FOR FURTHER INFORMATION CONTACT: 
    Wanda K. Jones, Dr.P.H., Interim Director, Office of Research 
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 
453-8200.

SUPPLEMENTARY INFORMATION: 
    Christian Kreipke, Ph.D., Wayne State University: ORI issued a 
charge letter enumerating findings of research misconduct and proposing 
HHS administrative actions. Dr. Kreipke (``Respondent'') subsequently 
requested a hearing before an Administrative Law Judge (ALJ) of the 
Departmental Appeals Board to dispute these findings. A hearing before 
the ALJ was held on July 10-12, 2017. On May 31, 2018, the ALJ issued 
his recommended decision, finding that Respondent recklessly caused or 
permitted twenty-three (23) instances of research misconduct in his 
three (3) grant applications, two (2) articles on which he was the 
first listed author, and two (2) posters on which he was the first 
listed author. The ALJ held that appropriate administrative actions 
included a five-year debarment from any contracting or subcontracting 
with any agency of the United States and from eligibility for or 
involvement in nonprocurement programs of the United States referred to 
as ``covered transactions.'' 2 CFR parts 180 and 376. The ALJ held it 
was an appropriate administrative action to also impose a five-year 
prohibition from serving in any capacity to the U.S. Public Health 
Service (PHS), including but not limited to, service on any PHS 
advisory committee, board, or peer review committee, or as a 
consultant. The ALJ noted that ORI also had proposed that the publisher 
of certain articles be notified of the need to retract those articles 
and that retraction had already occurred by the time of his recommended 
decision.
    Under the regulation, the ALJ's recommended decision went to the 
Assistant Secretary for Health, who did not modify it and forwarded it 
to the HHS Debarring Official, who is the deciding official for the 
debarment. The ALJ decision constituted the findings of fact to the HHS 
Debarring Official in accordance with 2 CFR 180.845(c). On July 13, 
2018, the HHS Debarring Official issued a final notice of debarment to 
begin on July 13, 2018, and end on July 12, 2023.

[[Page 38317]]

    Respondent's grant applications, articles, and posters in question 
examined the differential effects of endothelin receptor antagonists on 
traumatic brain injury-induced hypoperfusion of cerebral blood flow, 
neuronal cell injury, and cognition in rat animal models.
    Respondent recklessly included falsely described images in the 
following grant applications:

 R01 NS064976-01A1 submitted to NINDS, NIH (unfunded)
 R01 NS064976-01A2 submitted to NINDS, NIH (funded)
 R01 NS065824-01 submitted to NINDS, NIH (unfunded)

    Respondent recklessly included falsely described images in the 
following publications and posters:
     ``Differential effects of endothelin receptor A and B 
antagonism on cerebral hypoperfusion following traumatic brain 
injury.'' Neurological Research 32(2):209-14, 2010 Mar (``NR2010''). 
Retracted in Neurological Research 39(5):472, 2017 May.
     ``Clazosentan, a novel endothelin A antagonist, improves 
cerebral blood flow and behavior after traumatic brain injury.'' 
Neurological Research 33(2):208-13, 2011 Mar (``NR2011-1''). Retracted 
in Neurological Research 39(5):472, 2017 May.
     2009 poster for a Department of Veterans Affairs (VA) 
presentation: ``Using endothelin-A antagonists to ameliorate 
hypoperfusion and cognitive deficits following brain trauma: towards a 
clinical trial'' (``VA2009'').
     2010 poster for a VA presentation: ``Endothelin-1 receptor 
A antagonists improve neurologic and cognitive outcome following TBI'' 
(``VA2010'').
    The following findings of research misconduct were proven by a 
preponderance of the evidence. Respondent recklessly included:

 falsely described Fluoro-Jade stained images of rat brain 
cells in:
    --Figure 8 (left panel) in R01 NS064976-01A1
    --Figure 8B (left panel) in R01 NS064976-01A2
    --Figures 4A-F in R01 NS065824-01
    --Figure 3 (right and left panels) in NR2011-1
    --Figure 5C in NR2010
    --Figure 3 (panel 3) and Figure 6 (right and left panels) in VA2009
    --Figure 3 (panel 3) and Figure 6 (right and left panels) in VA2010
 falsely described systolic blood pressure curves in Figures 4A 
and 4B in NR2010
 falsely described cerebral blood flow graphs in:
    --Figure 5 (left panel) in R01 NS064976-01A1
    --Figure 5 (left panel) in R01 NS064976-01A2
    --Figure 3A in NR2010
    --Figure 5 in VA2009
    --Figure 5 in VA2010
 falsely described Western blot images in one of the following 
three grant applications (because at least one of the three must be 
false): Figure 1 (me+TBI panel for VEGF) in R01 NS065824-01, Figure 2B 
in R01 NS064976-01A1, and Figure 2B in R01 NS064976-01A2
 falsely described Western blot images in:
    --Figure 2A in R01 NS064976-01A1
    --Figure 2A in R01 NS064976-01A2
 a falsely described image of lectin labeled rat brain section 
in Figure 2C in R01 NS065824-01

    Thus, the research misconduct findings set forth above became 
effective, and the following administrative actions have been 
implemented for a period of five (5) years, beginning on July 13, 2018:
    (1) Dr. Kreipke is debarred 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) of Office of Management and Budget (OMB) Guidelines to 
Agencies on Governmentwide Debarment and Suspension (2 CFR part 180); 
and
    (2) Dr. Kreipke is prohibited 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.

Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018-16693 Filed 8-3-18; 8:45 am]
 BILLING CODE 4150-31-P
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