Findings of Research Misconduct, 16370-16371 [2018-07782]
Download as PDF
<![CDATA[
16370
Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT:
Sibyl Swift, Office of Dietary
Supplement Programs, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1455.
SUPPLEMENTARY INFORMATION:
srobinson on DSK3G9T082PROD with NOTICES
I. Background
We are announcing the availability of
a guidance for industry entitled ‘‘Highly
Concentrated Caffeine in Dietary
Supplements.’’ We are issuing this
guidance consistent with our good
guidance practices (GGP) regulation 21
CFR 10.115. In accordance with 21 CFR
§ 10.115(g)(2), we are issuing this
guidance without prior public comment
because we have determined that prior
public participation is not feasible or
appropriate in light of the threat to the
public health that is posed by pure and
highly concentrated caffeine products,
which have been linked to several
deaths in recent years. Although this
guidance is immediately in effect, it
remains subject to comment in
accordance with FDA’s GGP regulation.
In this guidance, we are announcing
that we consider some dietary
supplements containing high
concentrations of caffeine to be
adulterated and informing industry
about characteristics that are likely to
lead to products being considered
adulterated. A dietary supplement is
adulterated under section 402(f)(1)(A) of
the FD&C Act (21 U.S.C. 342(f)(1)(A)) if
it presents a significant or unreasonable
risk of illness or injury under the
conditions of use recommended or
suggested in the labeling or, if no
conditions for use are suggested or
recommended, under ordinary
conditions of use. In recent years, we
have seen the emergence of powdered
and liquid dietary supplement products
containing high concentrations of
caffeine marketed directly to consumers.
These products are often sold in bulk
containers with hundreds or thousands
of servings in the container, and even a
small dose can be toxic or deadly. The
consumer is required to measure out a
small, precise serving from what is often
a potentially lethal amount of product.
These products pose a significant or
unreasonable risk of illness or injury.
When formulated appropriately,
caffeine can be an ingredient in a
dietary supplement that does not
present a significant or unreasonable
risk of illness or injury. The guidance
provides suggestions on how
manufacturers can formulate safer
VerDate Sep<11>2014
19:42 Apr 13, 2018
Jkt 244001
dietary supplements containing caffeine
that do not present a significant or
unreasonable risk of illness or injury.
The guidance represents our current
thinking on dietary supplements
containing high concentrations of
caffeine. 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. Electronic Access
Persons with access to the internet
may obtain the document at either
https://www.fda.gov/FoodGuidances or
https://www.regulations.gov.
Dated: April 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07836 Filed 4–13–18; 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
April 2, 2018, the Department of Health
and Human Services (HHS) Debarring
Official, on behalf of the Secretary of
HHS, issued a final notice of debarment
based on the findings of research
misconduct made by the Office of
Research Integrity (ORI) against H.M.
Krishna Murthy, Ph.D., former Research
Associate Professor, Department of
Vision Sciences, University of Alabama
at Birmingham (UAB).
Dr. Murthy engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) grants,
specifically National Institute of Allergy
and Infectious Diseases (NIAID),
National Institutes of Health (NIH),
grants R01 AI051615, R01 AI032078,
and R01 AI045623; National Heart,
Lung, and Blood Institute (NHLBI), NIH,
grants P01 HL034343 and R01
HL064272; and National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), NIH, grant R01
DK046900. The administrative actions,
including ten (10) years of debarment,
were implemented beginning on April
2, 2018, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Interim
Director, Office of Research Integrity,
SUMMARY:
PO 00000
Frm 00086
Fmt 4703
Sfmt 4703
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
Notice is
hereby given that HHS has taken final
action in the following case:
H.M. Krishna Murthy, Ph.D.,
University of Alabama at Birmingham:
Based on evidence and findings of an
investigation conducted by UAB, ORI’s
review of UAB’s investigation, and
additional evidence obtained and
analysis conducted by ORI in its
oversight review of UAB’s investigation,
ORI found that Dr. H.M. Krishna Murthy
(Respondent), former Research
Associate Professor, Department of
Vision Sciences, UAB, committed
research misconduct in research
supported by PHS grants, specifically
NIAID, NIH, grants R01 AI051615, R01
AI032078, and R01 AI045623; NHLBI,
NIH, grants P01 HL034343 and R01
HL064272; and NIDDK, NIH, grant R01
DK046900.
Falsified and/or fabricated research
was reported in:
SUPPLEMENTARY INFORMATION:
• Nature 444:221–225, 2006 (hereafter
referred to as ‘‘Nature 2006’’); retracted in:
Nature 532:268, 2016 April 14
• J. Biol. Chem. 274:5573–5580, 1999
(hereafter referred to as ‘‘J. Biol. Chem.
1999’’); retracted in: J. Biol. Chem.
284:34468, 2009
• Proc. Natl. Acad. Sci. USA 101:8924–8929,
2004 (hereafter referred to as ‘‘PNAS
2004’’); Editorial Expression of Concern in:
PNAS 107:6551, 2010 April 6
• Biochem. 44:10757–10765, 2005 (hereafter
referred to as ‘‘Biochem. 2005’’)
• Proc. Natl. Acad. Sci. USA 103:2126–2131,
2006 (hereafter referred to as ‘‘PNAS
2006’’); Editorial Expression of Concern in:
PNAS 107:6551, 2010 April 6
• Acta Cryst. D55:1971–1977, 1999 (hereafter
referred to as ‘‘Acta Cryst. 1999’’); retracted
in: Acta Cryst. D66:222, 2010
• J. Mol. Biol. 301:759–767, 2000 (hereafter
referred to as ‘‘J. Mol. Biol. 2000’’);
retracted in: J. Mol. Biol. 397:1119, 2010
• Cell 104:301–311, 2001 (hereafter referred
to as ‘‘Cell 2001’’)
• Biochem. 41:11681–11691, 2002 (hereafter
referred to as ‘‘Biochem. 2002’’)
• Protein Data Bank (PDB) identification
codes 2HR0, 1BEF, 1RID, 1Y8E, 2A01,
1CMW, 2QID, 1DF9, 1G40, 1G44, 2OU1,
and 1L6L (the PDB is funded in part by
NIH)
Falsified and/or fabricated research results
also were referenced in the following PHS
grant applications:
• 1 R21 AI056224–01 submitted to NIAID,
NIH
• 1 R01 AI064509–01 submitted to NIAID,
NIH
• 1 R01 AI64509–01A1 submitted to NIAID,
NIH
• 1 R01 AI051615–01A1 submitted to NIAID,
NIH
• 1 R03 TW006840–01 submitted to Fogarty
International Center (FIC), NIH
E:\FR\FM\16APN1.SGM
16APN1
srobinson on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
ORI found by a preponderance of the
evidence that Respondent intentionally,
knowingly, or recklessly engaged in
research misconduct by falsifying and/
or fabricating X-ray crystallographic
data for eleven (11) protein structures
and falsely reporting them as
experimentally derived from X-ray
diffraction experiments in nine (9)
publications and in twelve (12) deposits
in the PDB. ORI found that Respondent
intentionally, knowingly, or recklessly
falsified and/or fabricated the PDB
coordinate files deposited for all of the
eleven (11) structures (PDB entries
2HR0, 1BEF, 1RID, 1Y8E, 2A01, 1CMW,
1G40, 1G44, 2OU1, 1L6L, 2QID, and
1DF9) and the X-ray diffraction data
(structure factors) corresponding to six
(6) of the eleven (11) structures (PDB
entries 2HR0, 1BEF, 1RID, 1Y8E, 2A01,
and 1CMW).
Specifically, Respondent falsified
and/or fabricated:
• The protein crystal structure of
complement component C3b reported
in Nature 2006 and the corresponding
structure factors and coordinate file
deposited in the PDB for entry 2HR0
• the protein crystal structure of dengue
virus NS3 serine protease reported in
J. Biol. Chem. 1999 and the
corresponding structure factors and
coordinate file deposited in the PDB
for entry 1BEF
• the protein crystal structure of
vaccinia virus complement control
protein (VCP) in complex with
heparin reported in PNAS 2004 and
the corresponding structure factors
and coordinate file deposited in the
PDB for entry 1RID
• the protein crystal structure of VCP in
complex with suramin (VCP-suramin)
reported in Biochem. 2005 and the
corresponding structure factors and
coordinate file deposited in the PDB
for entry 1Y8E
• the protein crystal structure of
apolipoprotein A–I reported in PNAS
2006 and the corresponding structure
factors and coordinate file deposited
in the PDB for entry 2A01
• the protein crystal structure of Taq
DNA polymerase reported in Acta
Cryst. 1999 and the corresponding
structure factors and coordinate file
deposited in the PDB for entry 1CMW
• the protein crystal structure of VCP
crystal form I reported in Cell 2001
and the corresponding coordinate
files deposited in the PDB for entry
1G40
• the protein crystal structure of VCP
crystal form II reported in Cell 2001
and the corresponding coordinate file
deposited in the PDB for entry 1G44
• the protein crystal structure of
apolipoprotein A–II reported in
VerDate Sep<11>2014
19:42 Apr 13, 2018
Jkt 244001
Biochem. 2002 and the corresponding
coordinate file deposited in the PDB
for entry 2OU1
• the protein crystal structure of
apolipoprotein A–II in complex with
b-octyl glucoside reported in
Biochem. 2002 and the corresponding
coordinate file deposited in the PDB
for entry IL6L
• the protein crystal structure of dengue
virus NS3 protease in complex with a
Bowman-Birk inhibitor reported in J.
Mol. Biol. 2000 and the corresponding
coordinate files deposited in the PDB
for entries 2QID and 1DF9
ORI issued a charge letter
enumerating the above findings of
research misconduct and proposing
HHS administrative actions. Respondent
subsequently requested a hearing before
an Administrative Law Judge (ALJ) of
the Departmental Appeals Board to
dispute these findings. ORI filed a
motion for summary judgment, which
Respondent opposed. On January 19,
2018, the ALJ issued a recommended
decision to the Acting Assistant
Secretary for Health (ASH) granting
summary judgment in favor of ORI and
sustaining ORI’s proposal to impose a
ten-year debarment and a ten-year ban
on PHS advisory services against
Respondent as well as correction of
Respondent’s research record. The
Acting ASH served a copy of the ALJ’s
recommended decision on the HHS
Debarring Official pursuant to 42 CFR
93.523(c), and the decision constituted
the findings of fact to the HHS
Debarring Official in accordance with 2
CFR 180.845(c). On April 2, 2018, the
HHS Debarring Official issued a final
notice of debarment to begin on April 2,
2018, and end on April 1, 2028. Thus,
the research misconduct findings set
forth above became effective, and the
following administrative actions have
been implemented, beginning on April
2, 2018:
(1) Dr. Murthy is debarred for a period
of ten (10) years from eligibility for any
contracting or subcontracting with any
agency of the United States Government
and from eligibility for 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);
(2) Dr. Murthy 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 for a period of ten (10) years;
and
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
16371
(3) ORI will send a notice to the
pertinent journals of the following
publications that require retraction or
correction and to the PDB for the
following entries that require
obsolescence, in accordance with 42
CFR 93.407(a)(1) and 93.411(b):
—Cell 104:301–311, 2001
—Biochem. 41:11681–11691, 2002
—Proc. Natl. Acad. Sci. USA 101:8924–
8929, 2004
—Biochem. 44:10757–10765, 2005
—Proc. Natl. Acad. Sci. USA 103:2126–
2131, 2006
—PDB entries 1RID, 1Y8E, 2A01, 1G40,
1G44, 2OU1, and 1L6L
Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018–07782 Filed 4–13–18; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Indian Health Professions Preparatory,
Indian Health Professions PreGraduate and Indian; Health
Professions Scholarship Programs
Announcement Type: Initial
CFDA Numbers: 93.971, 93.123, and 93.972
Key Dates
Application Deadline Date: April 13,
2018, 7:00 p.m. Eastern for continuing
students
Application Deadline Date: April 13,
2018, 7:00 p.m. Eastern for new
students
Application Review Date: May 7–25,
2018
Continuation Award Notification
Deadline Date: June 5, 2018
New Award Notification Deadline Date:
July 15, 2018
Award Start Date: August 1, 2018
Acceptance/Decline of Awards Deadline
Date: August 15, 2018
I. Funding Opportunity Description
The Indian Health Service (IHS) is
committed to encouraging American
Indians and Alaska Natives to enter the
health professions and to assuring the
availability of Indian health
professionals to serve Indians. The IHS
is committed to the recruitment of
students for the following programs:
• The Indian Health Professions
Preparatory Scholarship (Preparatory
Scholarship) authorized by Section 103
of the Indian Health Care Improvement
Act, Public Law 94–437 (1976), as
amended (IHCIA), codified at 25 U.S.C.
1613(b)(1).
• The Indian Health Professions Pregraduate Scholarship (Pre-graduate
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16370-16371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07782]
-----------------------------------------------------------------------
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 April 2, 2018, the Department
of Health and Human Services (HHS) Debarring Official, on behalf of the
Secretary of HHS, issued a final notice of debarment based on the
findings of research misconduct made by the Office of Research
Integrity (ORI) against H.M. Krishna Murthy, Ph.D., former Research
Associate Professor, Department of Vision Sciences, University of
Alabama at Birmingham (UAB).
Dr. Murthy engaged in research misconduct in research supported by
U.S. Public Health Service (PHS) grants, specifically National
Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health (NIH), grants R01 AI051615, R01 AI032078, and R01
AI045623; National Heart, Lung, and Blood Institute (NHLBI), NIH,
grants P01 HL034343 and R01 HL064272; and National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK), NIH, grant R01
DK046900. The administrative actions, including ten (10) years of
debarment, were implemented beginning on April 2, 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: Notice is hereby given that HHS has taken
final action in the following case:
H.M. Krishna Murthy, Ph.D., University of Alabama at Birmingham:
Based on evidence and findings of an investigation conducted by UAB,
ORI's review of UAB's investigation, and additional evidence obtained
and analysis conducted by ORI in its oversight review of UAB's
investigation, ORI found that Dr. H.M. Krishna Murthy (Respondent),
former Research Associate Professor, Department of Vision Sciences,
UAB, committed research misconduct in research supported by PHS grants,
specifically NIAID, NIH, grants R01 AI051615, R01 AI032078, and R01
AI045623; NHLBI, NIH, grants P01 HL034343 and R01 HL064272; and NIDDK,
NIH, grant R01 DK046900.
Falsified and/or fabricated research was reported in:
Nature 444:221-225, 2006 (hereafter referred to as ``Nature
2006''); retracted in: Nature 532:268, 2016 April 14
J. Biol. Chem. 274:5573-5580, 1999 (hereafter referred to
as ``J. Biol. Chem. 1999''); retracted in: J. Biol. Chem. 284:34468,
2009
Proc. Natl. Acad. Sci. USA 101:8924-8929, 2004 (hereafter
referred to as ``PNAS 2004''); Editorial Expression of Concern in:
PNAS 107:6551, 2010 April 6
Biochem. 44:10757-10765, 2005 (hereafter referred to as
``Biochem. 2005'')
Proc. Natl. Acad. Sci. USA 103:2126-2131, 2006 (hereafter
referred to as ``PNAS 2006''); Editorial Expression of Concern in:
PNAS 107:6551, 2010 April 6
Acta Cryst. D55:1971-1977, 1999 (hereafter referred to as
``Acta Cryst. 1999''); retracted in: Acta Cryst. D66:222, 2010
J. Mol. Biol. 301:759-767, 2000 (hereafter referred to as
``J. Mol. Biol. 2000''); retracted in: J. Mol. Biol. 397:1119, 2010
Cell 104:301-311, 2001 (hereafter referred to as ``Cell
2001'')
Biochem. 41:11681-11691, 2002 (hereafter referred to as
``Biochem. 2002'')
Protein Data Bank (PDB) identification codes 2HR0, 1BEF,
1RID, 1Y8E, 2A01, 1CMW, 2QID, 1DF9, 1G40, 1G44, 2OU1, and 1L6L (the
PDB is funded in part by NIH)
Falsified and/or fabricated research results also were
referenced in the following PHS grant applications:
1 R21 AI056224-01 submitted to NIAID, NIH
1 R01 AI064509-01 submitted to NIAID, NIH
1 R01 AI64509-01A1 submitted to NIAID, NIH
1 R01 AI051615-01A1 submitted to NIAID, NIH
1 R03 TW006840-01 submitted to Fogarty International Center
(FIC), NIH
[[Page 16371]]
ORI found by a preponderance of the evidence that Respondent
intentionally, knowingly, or recklessly engaged in research misconduct
by falsifying and/or fabricating X-ray crystallographic data for eleven
(11) protein structures and falsely reporting them as experimentally
derived from X-ray diffraction experiments in nine (9) publications and
in twelve (12) deposits in the PDB. ORI found that Respondent
intentionally, knowingly, or recklessly falsified and/or fabricated the
PDB coordinate files deposited for all of the eleven (11) structures
(PDB entries 2HR0, 1BEF, 1RID, 1Y8E, 2A01, 1CMW, 1G40, 1G44, 2OU1,
1L6L, 2QID, and 1DF9) and the X-ray diffraction data (structure
factors) corresponding to six (6) of the eleven (11) structures (PDB
entries 2HR0, 1BEF, 1RID, 1Y8E, 2A01, and 1CMW).
Specifically, Respondent falsified and/or fabricated:
The protein crystal structure of complement component C3b
reported in Nature 2006 and the corresponding structure factors and
coordinate file deposited in the PDB for entry 2HR0
the protein crystal structure of dengue virus NS3 serine
protease reported in J. Biol. Chem. 1999 and the corresponding
structure factors and coordinate file deposited in the PDB for entry
1BEF
the protein crystal structure of vaccinia virus complement
control protein (VCP) in complex with heparin reported in PNAS 2004 and
the corresponding structure factors and coordinate file deposited in
the PDB for entry 1RID
the protein crystal structure of VCP in complex with suramin
(VCP-suramin) reported in Biochem. 2005 and the corresponding structure
factors and coordinate file deposited in the PDB for entry 1Y8E
the protein crystal structure of apolipoprotein A-I reported
in PNAS 2006 and the corresponding structure factors and coordinate
file deposited in the PDB for entry 2A01
the protein crystal structure of Taq DNA polymerase reported
in Acta Cryst. 1999 and the corresponding structure factors and
coordinate file deposited in the PDB for entry 1CMW
the protein crystal structure of VCP crystal form I reported
in Cell 2001 and the corresponding coordinate files deposited in the
PDB for entry 1G40
the protein crystal structure of VCP crystal form II reported
in Cell 2001 and the corresponding coordinate file deposited in the PDB
for entry 1G44
the protein crystal structure of apolipoprotein A-II reported
in Biochem. 2002 and the corresponding coordinate file deposited in the
PDB for entry 2OU1
the protein crystal structure of apolipoprotein A-II in
complex with [beta]-octyl glucoside reported in Biochem. 2002 and the
corresponding coordinate file deposited in the PDB for entry IL6L
the protein crystal structure of dengue virus NS3 protease in
complex with a Bowman-Birk inhibitor reported in J. Mol. Biol. 2000 and
the corresponding coordinate files deposited in the PDB for entries
2QID and 1DF9
ORI issued a charge letter enumerating the above findings of
research misconduct and proposing HHS administrative actions.
Respondent subsequently requested a hearing before an Administrative
Law Judge (ALJ) of the Departmental Appeals Board to dispute these
findings. ORI filed a motion for summary judgment, which Respondent
opposed. On January 19, 2018, the ALJ issued a recommended decision to
the Acting Assistant Secretary for Health (ASH) granting summary
judgment in favor of ORI and sustaining ORI's proposal to impose a ten-
year debarment and a ten-year ban on PHS advisory services against
Respondent as well as correction of Respondent's research record. The
Acting ASH served a copy of the ALJ's recommended decision on the HHS
Debarring Official pursuant to 42 CFR 93.523(c), and the decision
constituted the findings of fact to the HHS Debarring Official in
accordance with 2 CFR 180.845(c). On April 2, 2018, the HHS Debarring
Official issued a final notice of debarment to begin on April 2, 2018,
and end on April 1, 2028. Thus, the research misconduct findings set
forth above became effective, and the following administrative actions
have been implemented, beginning on April 2, 2018:
(1) Dr. Murthy is debarred for a period of ten (10) years from
eligibility for any contracting or subcontracting with any agency of
the United States Government and from eligibility for 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);
(2) Dr. Murthy 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 for
a period of ten (10) years; and
(3) ORI will send a notice to the pertinent journals of the
following publications that require retraction or correction and to the
PDB for the following entries that require obsolescence, in accordance
with 42 CFR 93.407(a)(1) and 93.411(b):
--Cell 104:301-311, 2001
--Biochem. 41:11681-11691, 2002
--Proc. Natl. Acad. Sci. USA 101:8924-8929, 2004
--Biochem. 44:10757-10765, 2005
--Proc. Natl. Acad. Sci. USA 103:2126-2131, 2006
--PDB entries 1RID, 1Y8E, 2A01, 1G40, 1G44, 2OU1, and 1L6L
Wanda K. Jones,
Interim Director, Office of Research Integrity.
[FR Doc. 2018-07782 Filed 4-13-18; 8:45 am]
BILLING CODE 4150-31-P
