Findings of Research Misconduct, 25274-25275 [2013-10085]
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Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Notices
Secretary for Preparedness and
Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FD&C Act,
the Commissioner of the Food and Drug
Administration (FDA), acting under
delegated authority from the Secretary
of HHS, may issue an Emergency Use
Authorization (EUA): (1) Authorizing
the emergency use of an unapproved
drug, an unapproved or uncleared
device, or an unlicensed biological
product; or (2) an unapproved use of an
approved drug, approved or cleared
device, or licensed biological product.
Before an EUA may be issued, the
Secretary of HHS must declare an
emergency justifying the authorization
based on one of four determinations: (1)
A determination of a domestic
emergency, or a significant potential for
a domestic emergency, by the Secretary
of Homeland Security; (2) the
identification of a material threat by the
Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act 2 sufficient to
affect national security or the health and
security of United States citizens living
abroad; (3) a determination of a military
emergency, or a significant potential for
a military emergency, by the Secretary
of Defense; or (4) a determination by the
Secretary that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of United States citizens living
abroad, and that involves a biological,
chemical, radiological, or nuclear agent
or agents, or a disease or condition that
may be attributable to such agent or
agents (see 21 U.S.C. 360bbb–3(b)(1)).3
Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
exist that justify the EUA, at which
point the FDA Commissioner may issue
an EUA if the criteria for issuance of an
2 42
U.S.C. 247d–6b.
amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
5, the Secretary may make determination of a public
health emergency, or a significant potential for a
public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to
make a determination of a public health emergency
in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
declaration made under section 564 of the FD&C
Act.
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authorization under section 564 of the
FD&C Act are met.
The Centers for Disease Control and
Prevention (CDC), HHS, requested that
the FDA, HHS, issue an EUA for in vitro
diagnostics for detection of the avian
influenza A (H7N9) virus to allow the
Department to take preparedness
measures based on information
currently available about the avian
influenza A (H7N9) virus detected in
China. The determination of a
significant potential for a public health
emergency, and the declaration that
circumstances exist justifying
emergency use of in vitro diagnostics for
detection of the avian influenza A
(H7N9) virus by the Secretary of HHS,
as described below, enable the FDA
Commissioner to issue an EUA for
certain in vitro diagnostics for
emergency use under section 564(a) of
the FD&C Act, 21 U.S.C. 360bbb–3(a).
II. Determination by the Secretary of
Health and Human Services
On April 19, 2013, pursuant to section
564(b)(1)(C) of the FD&C Act, 21 U.S.C.
360bbb–3(b)(1)(C), I determined that
there is a significant potential for a
public health emergency that has a
significant potential to affect national
security or the health and security of
United States citizens living abroad and
that involves the avian influenza A
(H7N9) virus.
III. Declaration of the Secretary of
Health and Human Services
Also on April 19, 2013, on the basis
of my determination of a significant
potential for a public health emergency
that has a significant potential to affect
national security or the health and
security of United States citizens living
abroad and that involves the avian
influenza A (H7N9) virus, I declared
that circumstances exist justifying the
authorization of emergency use of in
vitro diagnostics for detection of the
avian influenza A (H7N9) virus
pursuant to section 564 of the FD&C
Act, 21 U.S.C. 360bbb–3, subject to the
terms of any authorization issued under
that section.
I also specified that this declaration is
a declaration of an emergency with
respect to in vitro diagnostics as defined
under the PREP Act Declaration for
Pandemic Influenza Diagnostics,
Personal Respiratory Protection Devices,
and Respiratory Support Devices signed
by then Secretary Michael Leavitt on
December 17, 2008.
Notice of the EUAs issued by the FDA
Commissioner pursuant to this
determination and declaration will be
provided promptly in the Federal
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Register as required under 21 U.S.C.
360bbb–3(h).
Dated: April 19, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013–10055 Filed 4–29–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Matthew Poore, Advanced Liquid
Logic Inc.: Based on the report of an
inquiry conducted by Advanced Liquid
Logic Inc. (Liquid Logic), the
Respondent’s admission, and additional
analysis conducted by ORI, ORI found
that Mr. Matthew Poore, former
Technician, Liquid Logic, engaged in
research misconduct in research
supported by National Institute of
Allergy and Infectious Diseases (NIAID),
National Institutes of Health (NIH),
contract HHSN272200900030C.
ORI found that the Respondent
engaged in research misconduct by
falsifying data that were included in one
(1) presentation and one (1) report to
NIAID and in laboratory records at
Liquid Logic.
ORI finds that Respondent knowingly
and intentionally falsified reverse
transcription-polymerase chain reaction
(RT–PCR) results by reporting the
results from previous experiments as the
actual results, when the experiments
had not been performed. Specifically:
• In Liquid Logic laboratory
documents, the Respondent falsified the
RT–PCR results of human
immunodeficiency virus (HIV) viral
loads in whole blood patient samples by
falsely changing previous results for two
(2) samples from negative to positive
and one (1) sample from positive to
negative. The latter falsified sample
result, changed from HIV positive to
negative, was included in an April 1–
June 30, 2012, quarterly report and a
July 12, 2012, presentation to NIAID.
• In Liquid Logic laboratory
documents, the Respondent falsified the
RT–PCR whole blood lysis results of
testing samples as 100 and 200 HIV viral
copies per milliliter, when the
experiments were not performed by the
Respondent. These falsified results were
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Federal Register / Vol. 78, No. 83 / Tuesday, April 30, 2013 / Notices
included in an April 1–June 30, 2012,
quarterly report to NIAID.
• In Liquid Logic laboratory
documents, the Respondent falsified the
graphs of RT–PCR results of the
Escherichia coli bacteriophage MS2, an
internal control, viral loads for three (3)
clinical samples, when the results were
actually from prior experiments of two
(2) controls and one (1) unrelated
clinical sample. The Respondent
falsified the MS2 graphs in an effort to
conceal that RT–PCR experiments of the
clinical samples had not been
performed.
Mr. Poore has entered into a
Voluntary Settlement Agreement and
has voluntarily agreed for a period of
three (3) years, beginning on April 1,
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;
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 FURTHER INFORMATION CONTACT:
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013–10085 Filed 4–29–13; 8:45 am]
BILLING CODE 4150–31–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Chronic Fatigue
Syndrome Advisory Committee
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
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SUMMARY: As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Chronic Fatigue Syndrome Advisory
Committee (CFSAC) will hold a
meeting. The meeting will be open to
the public.
DATES: The meeting will be held on
Wednesday, May 22, 2013, and
Thursday, May 23, 2013, from 9:00 a.m.
until 5:00 p.m.
ADDRESSES: Department of Health and
Human Services; Hubert H. Humphrey
Building; 200 Independence Avenue
SW., Room 800; Washington, DC 20201.
For a map and directions to the Hubert
H. Humphrey building, please visit
https://www.hhs.gov/about/
hhhmap.html.
FOR FURTHER INFORMATION CONTACT:
Nancy C. Lee, M.D., Designated Federal
Officer, Chronic Fatigue Syndrome
Advisory Committee, Department of
Health and Human Services, 200
Independence Avenue SW., Room 712E,
Washington, DC 20201. Any questions
about meeting registration or public
comment sign-up should be directed to
CFSACMay2013@seamon
corporation.com. Please direct other
inquiries to cfsac@hhs.gov.
SUPPLEMENTARY INFORMATION: CFSAC
was established on September 5, 2002,
to advise, consult with, and make
recommendations to the Secretary,
through the Assistant Secretary for
Health, on a broad range of topics
including: (1) The current state of
knowledge and research and the
relevant gaps in knowledge and research
about the epidemiology, etiologies,
biomarkers, and risk factors relating to
CFS, and identifying potential
opportunities in these areas; (2) impact
and implications of current and
proposed diagnosis and treatment
methods for CFS; (3) development and
implementation of programs to inform
the public, health care professionals,
and the biomedical academic and
research communities about CFS
advances; and (4) partnering to improve
the quality of life of CFS patients.
The agenda for this meeting is being
developed and will be posted on the
CFSAC Web site, https://www.hhs.gov/
advcomcfs when finalized. The meeting
will be live-video streamed at
www.HHS.gov/Live and archived
through the CFSAC Web site:
www.hhs.gov/advocomcfs. Listeningonly audio via telephone will be
available on both days. Call-in
information will be posted on the
CFSAC Web site.
Individuals who plan to attend should
register at the following link by May 17,
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2013: https://www.blsmeetings.net/
CFSACMay2013. Attendance by visitors
who are not U.S. citizens is welcome,
but prior approval is required by
sending a request to
CFSACMay2013@seamon
corporation.com before May 8, 2013.
Members of the media will also need to
register. All attendees will be required
to show government-issued picture
identification (state or federal) for entry
into a federal building. Attendees will
receive a wrist band that must be worn
the entire time. Security requires all
non-federal employees to be escorted
the entire time they are in the building.
Upon leaving the building for any
reason, all persons will be required to
follow the security steps mentioned
above and receive a new wrist band.
Members of the public will have the
opportunity to provide public comment
at the meeting or via telephone.
International calls cannot be
accommodated. You are no longer
required to submit a written copy of
your testimony as in past years unless
you wish to have it included in the
public record. Individuals wishing to
submit public comment for public
record must send an electronic copy of
their testimony in advance to:
CFSACMay2013@seamon
corporation.com by Wednesday, May
15, 2013. A separate sign-up process for
requesting time for public comment
must be completed by Wednesday, May
15, 2013 at the following link: https://
www.blsmeetings.net/CFSACPublic
CommentMay2013. An email to
acknowledge receipt of the request for
public comment will be sent from this
email address. The document for public
record must not exceed 5 single-spaced,
typed pages, using a 12-point typeface;
it is preferred that the document be
prepared in the MSWord format. Please
note that PDF files, handwritten notes,
charts, and photographs that are
submitted for distribution to the
Committee will not be posted on the
CFSAC Web site. However, this material
will be made available for the public to
view on site during the dates that the
meeting is being conducted. Individuals
who wish to view this material after the
meeting should contact the CFSAC
DFO, whose contact information is
included in this Federal Register notice.
Requests to participate in the public
comment and provide written testimony
will not be accepted through the CFSAC
mailbox. Also, the CFSAC mailbox will
not respond to questions about specific
public comment requests. These
requests and/or inquiries should be
directed to CFSACMay2013@seamon
corporation.com.
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[Federal Register Volume 78, Number 83 (Tuesday, April 30, 2013)]
[Notices]
[Pages 25274-25275]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10085]
-----------------------------------------------------------------------
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 the Office of Research Integrity
(ORI) has taken final action in the following case:
Matthew Poore, Advanced Liquid Logic Inc.: Based on the report of
an inquiry conducted by Advanced Liquid Logic Inc. (Liquid Logic), the
Respondent's admission, and additional analysis conducted by ORI, ORI
found that Mr. Matthew Poore, former Technician, Liquid Logic, engaged
in research misconduct in research supported by National Institute of
Allergy and Infectious Diseases (NIAID), National Institutes of Health
(NIH), contract HHSN272200900030C.
ORI found that the Respondent engaged in research misconduct by
falsifying data that were included in one (1) presentation and one (1)
report to NIAID and in laboratory records at Liquid Logic.
ORI finds that Respondent knowingly and intentionally falsified
reverse transcription-polymerase chain reaction (RT-PCR) results by
reporting the results from previous experiments as the actual results,
when the experiments had not been performed. Specifically:
In Liquid Logic laboratory documents, the Respondent
falsified the RT-PCR results of human immunodeficiency virus (HIV)
viral loads in whole blood patient samples by falsely changing previous
results for two (2) samples from negative to positive and one (1)
sample from positive to negative. The latter falsified sample result,
changed from HIV positive to negative, was included in an April 1-June
30, 2012, quarterly report and a July 12, 2012, presentation to NIAID.
In Liquid Logic laboratory documents, the Respondent
falsified the RT-PCR whole blood lysis results of testing samples as
100 and 200 HIV viral copies per milliliter, when the experiments were
not performed by the Respondent. These falsified results were
[[Page 25275]]
included in an April 1-June 30, 2012, quarterly report to NIAID.
In Liquid Logic laboratory documents, the Respondent
falsified the graphs of RT-PCR results of the Escherichia coli
bacteriophage MS2, an internal control, viral loads for three (3)
clinical samples, when the results were actually from prior experiments
of two (2) controls and one (1) unrelated clinical sample. The
Respondent falsified the MS2 graphs in an effort to conceal that RT-PCR
experiments of the clinical samples had not been performed.
Mr. Poore has entered into a Voluntary Settlement Agreement and has
voluntarily agreed for a period of three (3) years, beginning on April
1, 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; 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 FURTHER INFORMATION CONTACT: Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240)
453-8200.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013-10085 Filed 4-29-13; 8:45 am]
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