Findings of Research Misconduct, 64947-64948 [2011-27022]
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Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Notices
approved by the Food and Drug
Administration (‘‘FDA’’) in 2007. No
companies currently market a generic
version of Amrix, but Teva and
Cephalon (through an authorized
generic product 1) are two of a limited
number of suppliers capable of entering
with a generic cyclobenzaprine
hydrochloride product in a timely
manner.
Modafinil tablets treat excessive
sleepiness caused by narcolepsy or shift
work disorder. Cephalon markets
modafinil tablets under the brand name
Provigil, sales of which totaled
approximately $1 billion in 2010. No
companies currently market a generic
version of Provigil. Teva, Ranbaxy
Pharmaceuticals, Inc., Mylan
Pharmaceutical Inc., and Barr
Laboratories, Inc. (now owned by Teva)
each filed applications seeking FDA
approval to market generic Provigil
before expiration of Cephalon’s patent.
They all filed on the first day that the
FDA would accept such an application,
making them all eligible for the 180-day
marketing exclusivity period provided
under the Hatch-Waxman Act.2
Subsequently, each of the companies
agreed with Cephalon to refrain from
marketing generic Provigil until April
2012. Cephalon (through an authorized
generic product) and Teva are two of a
limited number of suppliers bestpositioned to enter with a generic
modafinil product during the upcoming
Hatch-Waxman exclusivity period for
sales of generic modafinil.
emcdonald on DSK5VPTVN1PROD with NOTICES
Entry
Entry into the markets for fentanyl
citrate, cyclobenzaprine hydrochloride,
and modafinil would not be timely,
likely, or sufficient in magnitude,
character, and scope to deter or
counteract the anticompetitive effects of
the acquisition. The combination of
drug development times and regulatory
requirements, including FDA approval,
takes at least two years. And even
companies for whom the FDA approval
process is well underway face other
regulatory barriers, including HatchWaxman regulatory exclusivity and
1 Authorized generic products are manufactured
by branded pharmaceutical companies and
marketed and sold under a non-brand label at
generic prices.
2 Under the Hatch-Waxman Act, if a generic
company plans to launch a generic version of a
pharmaceutical product before the patents covering
the branded product expire it must certify that its
product does not infringe the branded company’s
patents or that the branded company’s patents are
invalid. The certification usually results in patent
litigation. If the generic company successfully
challenges the patents held by the branded
company, the generic company may be eligible to
receive a 180-day period of market exclusivity for
its generic product.
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16:34 Oct 18, 2011
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pending patent litigation, that limit their
ability to enter these markets in a timely
manner.
Effects
The Proposed Acquisition would
cause significant anticompetitive harm
to consumers in the U.S. markets for
fentanyl citrate, cyclobenzaprine
hydrochloride, and modafinil. In
pharmaceuticals markets with generic
competition, price generally decreases
as the second, third, fourth, and even
fifth competitors enter. Although
generic versions of cyclobenzaprine
hydrochloride and modafinil are not yet
available in the United States, the FDA
approval process provides information
about the timeliness and likeliness of
entry by generic products. In addition,
substantial experience and empirical
evidence of the impact of multiple
generic suppliers on prices for other
drugs provide a strong basis to draw
conclusions about the likely effects of
the Proposed Acquisition in the markets
for these products. Moreover, for a drug
with high dollar sales such as Provigil,
the impact from a reduction of
competition during the 180-day
exclusivity period alone is substantial.
The Proposed Acquisition, by reducing
an already limited number of
competitors or potential competitors in
each of these markets, would cause
anticompetitive harm to U.S. consumers
by increasing the likelihood of higher
post-acquisition prices.
The Consent Agreement
The proposed Consent Agreement
effectively remedies the Proposed
Acquisition’s anticompetitive effects in
the relevant markets by requiring Teva
to divest certain rights and assets related
to generic fentanyl citrate and generic
cyclobenzaprine hydrochloride to a
Commission-approved acquirer no later
than ten days after the acquisition. In
addition, to remedy the consolidation of
marketers of generic modafinil during
the exclusivity period, the Consent
Agreement requires Teva to enter into a
supply agreement to provide a
Commission-approved acquirer with
generic modafinil tablets to sell in the
United States for at least one year. The
acquirer of the divested assets must
receive the prior approval of the
Commission. The Commission’s goal in
evaluating a possible purchaser of
divested assets is to maintain the
competitive environment that existed
prior to the acquisition.
The proposed Consent Agreement
remedies the competitive concerns the
acquisition raises by requiring Teva to
divest its generic fentanyl citrate and
generic cyclobenzaprine hydrochloride
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64947
to Par, which will purchase all rights
currently held by Teva. In addition,
Teva will supply Par with at least a oneyear supply of modafinil tablets. Par has
the option to extend the modafinil
supply agreement for an additional year.
Par is a New Jersey-based generic
pharmaceutical company with 115
active products and an active product
development pipeline. With its
experience in generic markets, Par is
expected to replicate the competition
that would otherwise be lost with the
Proposed Acquisition.
If the Commission determines that Par
is not an acceptable acquirer of the
assets to be divested, or that the manner
of the divestitures is not acceptable, the
parties must unwind the sale to Par and
divest the products, within six months
of the date the Order becomes final, to
a Commission-approved acquirer. In
that circumstance, the Commission may
appoint a trustee to divest the products
if Teva fails to divest the products as
required.
The proposed Consent Agreement
contains several provisions to help
ensure that the divestitures are
successful. The Order requires Teva to
take all action to maintain the economic
viability, marketability, and
competitiveness of the products until
such time as they are transferred to a
Commission-approved acquirer. Teva
must transfer the manufacturing
technology for the fentanyl citrate and
cyclobenzaprine hydrochloride
products to Par and must supply Par
with fentanyl citrate and
cyclobenzaprine hydrochloride
products during the transition period.
The purpose of this analysis is to
facilitate public comment on the
proposed Consent Agreement, and it is
not intended to constitute an official
interpretation of the proposed Order or
to modify its terms in any way.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2011–26970 Filed 10–18–11; 8:45 am]
BILLING CODE 6750–01–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 the Office
of Research Integrity (ORI) has taken
final action in the following case:
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emcdonald on DSK5VPTVN1PROD with NOTICES
64948
Federal Register / Vol. 76, No. 202 / Wednesday, October 19, 2011 / Notices
Marija Manojlovic, University of
Pittsburgh: Based on an inquiry
conducted and written admission
obtained by the University of Pittsburgh
(UP) and additional analysis conducted
by ORI in its oversight review, ORI
found that Ms. Marija Manojlovic,
former graduate student, Department of
Chemistry, UP, engaged in research
misconduct in research supported by
National Institute of General Medical
Sciences (NIGMS), National Institutes of
Health (NIH), grant P50 GM067082,
National Cancer Institute (NCI), NIH,
grant P01 CA078039, National Institute
of Mental Health (NIMH), NIH, grant
U54 MH074411, and National Institute
of Allergy and Infectious Diseases
(NIAID), NIH, grant R01 AI033506.
ORI found that the Respondent
engaged in research misconduct by
falsifying and fabricating the synthesis
and spectral data that were included in
one (1) poster presentation and in one
(1) pre-submission draft of a paper to be
submitted for publication.
Specifically, ORI found that the
Respondent knowingly falsified and
fabricated the synthesis and
characterization, largely in the form of
manipulated 1H- and 13C–NMR spectral
data, for five intermediate steps and the
final product, 9-desmethylpleurotin,
and presented these false results in a
poster, ‘‘Efforts Towards the Total
Synthesis of Pleurotin,’’ presented at the
2011 National Organic Symposium, and
in a manuscript, ‘‘Total Synthesis of 9desmethylpleurotin,’’ prepared for
submission to Angewandte Chemie
International Edition.
Ms. Manojlovic has voluntarily agreed
for a period of three (3) years, beginning
on September 26, 2011:
(1) To have her U.S. Public Health
Service (PHS)-supported research
supervised; Respondent agreed that
prior to the submission of an
application for PHS support for a
research project on which her
participation is proposed and prior to
her participation in any capacity on
PHS-supported research, she shall
ensure that a plan for supervision of her
duties is submitted to ORI for approval;
the supervision plan must be designed
to ensure the scientific integrity of her
research contribution; Respondent
agreed that she 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 her
shall submit, in conjunction with each
application for PHS funds, or report,
manuscript, or abstract involving PHSsupported research in which she is
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16:34 Oct 18, 2011
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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 herself 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, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
John Dahlberg,
Director, Division of Investigative Oversight,
Office of Research Integrity.
[FR Doc. 2011–27022 Filed 10–18–11; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Decision To Evaluate a Petition To
Designate a Class of Employees From
Oak Ridge National Laboratory (X–10),
Oak Ridge, TN, To Be Included in the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
HHS gives notice as required
by 42 CFR 83.12(e) of a decision to
evaluate a petition to designate a class
of employees from Oak Ridge National
Laboratory (X–10), Oak Ridge,
Tennessee, to be included in the Special
Exposure Cohort under the Energy
Employees Occupational Illness
Compensation Program Act of 2000. The
initial proposed definition for the class
being evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Oak Ridge National
Laboratory (X–10)
Location: Oak Ridge, Tennessee.
Job Titles and/or Job Duties: All
contractor employees, subcontractor
employees, and AEC employees who
were monitored or should have been
monitored for any of the various
radionuclides and fission products
present at the X–10 plant.
Period of Employment: January 1,
1943 through December 31, 1952.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
SUMMARY:
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Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone 877–
222–7570. Information requests can also
be submitted by e-mail to
DCAS@CDC.GOV.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2011–27035 Filed 10–18–11; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Senior Executive Service
Performance Review Board
Membership
The Agency for Healthcare Research
and Quality (AHRQ) announces the
appointment of members to the AHRQ
Senior Executive Service (SES)
Performance Review Board (PRB). This
action is being taken in accordance with
5 U.S.C. 4314(c)(4), which requires
notice of appointment of members to
performance review boards to be
published in the Federal Register.
Members of the PRB are appointed in
a manner that will ensure consistency,
stability and objectivity in the SES
performance appraisals. The function of
the PRB is to make recommendations to
the Director, AHRQ, relating to the
performance of senior executives in the
Agency.
The following persons will serve on
the AHRQ SES Performance Review
Board:
Irene Fraser, Stephen B. Cohen, William
Munier, David Meyers, Michael
Fitzmaurice, Phyllis Zucker, Mark
Handelman, Jean Slutsky.
For further information about the
AHRQ Performance Review Board,
contact Ms. Alison Reinheimer, Office
of Performance, Accountability,
Resources, and Technology, Agency for
Healthcare Research and Quality, 540
Gaither Road, Suite 4012, Rockville,
Maryland 20850.
Dated: October 2, 2011.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2011–26965 Filed 10–18–11; 8:45 am]
BILLING CODE 4160–90–M
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]]>Agencies
[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Pages 64947-64948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27022]
=======================================================================
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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.
-----------------------------------------------------------------------
Notice is hereby given that the Office of Research Integrity (ORI)
has taken final action in the following case:
[[Page 64948]]
Marija Manojlovic, University of Pittsburgh: Based on an inquiry
conducted and written admission obtained by the University of
Pittsburgh (UP) and additional analysis conducted by ORI in its
oversight review, ORI found that Ms. Marija Manojlovic, former graduate
student, Department of Chemistry, UP, engaged in research misconduct in
research supported by National Institute of General Medical Sciences
(NIGMS), National Institutes of Health (NIH), grant P50 GM067082,
National Cancer Institute (NCI), NIH, grant P01 CA078039, National
Institute of Mental Health (NIMH), NIH, grant U54 MH074411, and
National Institute of Allergy and Infectious Diseases (NIAID), NIH,
grant R01 AI033506.
ORI found that the Respondent engaged in research misconduct by
falsifying and fabricating the synthesis and spectral data that were
included in one (1) poster presentation and in one (1) pre-submission
draft of a paper to be submitted for publication.
Specifically, ORI found that the Respondent knowingly falsified and
fabricated the synthesis and characterization, largely in the form of
manipulated 1H- and 13C-NMR spectral data, for five intermediate steps
and the final product, 9-desmethylpleurotin, and presented these false
results in a poster, ``Efforts Towards the Total Synthesis of
Pleurotin,'' presented at the 2011 National Organic Symposium, and in a
manuscript, ``Total Synthesis of 9-desmethylpleurotin,'' prepared for
submission to Angewandte Chemie International Edition.
Ms. Manojlovic has voluntarily agreed for a period of three (3)
years, beginning on September 26, 2011:
(1) To have her U.S. Public Health Service (PHS)-supported research
supervised; Respondent agreed that prior to the submission of an
application for PHS support for a research project on which her
participation is proposed and prior to her participation in any
capacity on PHS-supported research, she shall ensure that a plan for
supervision of her duties is submitted to ORI for approval; the
supervision plan must be designed to ensure the scientific integrity of
her research contribution; Respondent agreed that she 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 her shall submit, in conjunction
with each application for PHS funds, or report, manuscript, or abstract
involving PHS-supported research in which she 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 herself 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, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453-8800.
John Dahlberg,
Director, Division of Investigative Oversight, Office of Research
Integrity.
[FR Doc. 2011-27022 Filed 10-18-11; 8:45 am]
BILLING CODE 4150-31-P
