Findings of Research Misconduct, 36150-36151 [2017-16311]
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36150
Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices
The Food and Drug
Administration (FDA) is publishing
notice that an applicant for a proposed
biosimilar product notified FDA that a
patent infringement action was filed in
connection with the applicant’s
biologics license application (BLA).
Under the Public Health Service Act
(PHS Act), an applicant for a proposed
biosimilar product or interchangeable
product must notify FDA within 30 days
after the applicant was served with a
complaint in a patent infringement
action described under the PHS Act.
FDA is required to publish notice of the
complaint in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6246, Silver Spring,
MD 20993–0002, 240–402–0979,
daniel.orr@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was
enacted as part of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148) on March 23, 2010. The BPCI Act
amended the PHS Act and created an
abbreviated licensure pathway for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product. Section 351(k) of the PHS Act
(42 U.S.C. 262(k)), added by the BPCI
Act, describes the requirements for a
BLA for a proposed biosimilar product
or a proposed interchangeable product
(351(k) BLA). Section 351(l) of the PHS
Act, also added by the BPCI Act,
describes certain procedures for
exchanging patent information and
SUMMARY:
resolving patent disputes between a
351(k) BLA applicant and the holder of
the BLA reference product. If a 351(k)
applicant is served with a complaint for
a patent infringement described in
section 351(l)(6) of the PHS Act, the
applicant is required to provide FDA
with notice and a copy of the complaint
within 30 days of service. FDA is
required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
FDA received notice of the following
complaint under section 351(l)(6)(C) of
the PHS Act: Amgen, Inc., et al. v.
Coherus Biosciences, Inc., 17–cv–00546
(D. Del., filed May 10, 2017).
FDA has only a ministerial role in
publishing notice of a complaint
received under section 351(l)(6)(C) of
the PHS Act and does not perform a
substantive review of the complaint.
ACTION:
Dated: July 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2017–16380 Filed 8–2–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0002]
B. Braun Medical, Inc.; Withdrawal of
Approval of Three New Drug
Applications and One Abbreviated New
Drug Application
AGENCY:
mstockstill on DSK30JT082PROD with NOTICES
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn, effective
September 5, 2017. Introduction or
delivery for introduction into interstate
commerce for products without an
approved NDA or ANDA violates
section 301(a) and (d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
331(a) and (d)). Drug products that are
listed in the table that are in inventory
on the date that this notice becomes
effective (see the DATES section) may
continue to be dispensed until the
inventories have been depleted or the
16:35 Aug 02, 2017
DATES:
Effective September 5, 2017.
FOR FURTHER INFORMATION CONTACT:
Valerie A. Butler, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
B. Braun
Medical, Inc., 901 Marcon Blvd.,
Allentown, PA 18109, has informed
FDA that the following three NDAs and
one ANDA are no longer marketed and
has requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). By its request, B. Braun
Medical, Inc., has also waived its
opportunity for a hearing. Withdrawal
of approval of an application under
§ 314.150(c) is without prejudice to
refiling.
Food and Drug Administration,
Proprietary name
....................................................
....................................................
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.....................................................
VerDate Sep<11>2014
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of three new drug
applications (NDAs) and one
abbreviated new drug application
(ANDA) held by B. Braun Medical, Inc.
B. Braun Medical, Inc., notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
SUMMARY:
HHS.
NDA/ANDA
BN 090024
BN 160767
BN 890104
BA 740283
Notice.
Jkt 241001
Dextran 70, 6% Dextran 70 in 0.9% NaCl Injection.
Dextran 40, 10% Dextran 40 in 0.9% NaCl Injection and 10% Dextran 40 in 5% Dextrose.
Pentaspan® (10% Pentastarch in 0.9% NaCl Injection in EXCEL Containers).
Hespan® (6% Hetastarch in 0.9% NaCl in EXCEL Containers).
drug products have reached their
expiration dates or otherwise becomes
violative, whichever occurs first.
Dated: July 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–16377 Filed 8–2–17; 8:45 am]
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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:
Nasser Chegini, Ph.D., University of
Florida: Based on the report of an
investigation conducted by the
University of Florida (UF), the prior
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices
corrections in the scientific record noted
below, and additional analysis
conducted by ORI in its oversight
review, ORI found that Dr. Nasser
Chegini, retired as a Professor in the
Department of Obstetrics and
Gynecology, UF, engaged in research
misconduct in research supported by
National Institute of Child Health and
Human Development (NICHD), National
Institutes of Health (NIH), grant 2 R01
HD037432.
ORI acknowledges that the following
papers were retracted as a result of the
institution’s investigation:
mstockstill on DSK30JT082PROD with NOTICES
1. J Clin Endocrinol Metab 88(10):4967–4976,
2003. Retraction in: J Clin Endocrinol
Metab 100(1):318, 2015 Jan.
2. Reprod Biol Endocrinol 1:125, 2003.
Retraction in: Reprod Biol Endocrinol
13:25, 2015 Apr 3.
3. J Clin Endocrinol Metab 88(3):1350–1361,
2003. Retraction in: J Clin Endocrinol
Metab 100(1):318, 2015 Jan.
4. Hum Reprod 21(10):2555–2563, 2006.
Retraction in: Hum Reprod 30(1):249,
2015 Jan (Epub 2014 Nov 6).
5. Mol Hum Reprod 12(4):245–256, 2006.
Retraction in: Mol Hum Reprod
20(12):1258, 2014 Dec (Epub 2014 Nov
13).
6. Mol Hum Reprod 13(11):797–806, 2007.
Retraction in: Mol Hum Reprod
20(12):1259, 2014 Dec (Epub 2014 Nov
13).
7. Reprod Sci 15(10):993–1001, 2007.
Retraction in: Reprod Sci 21(10):1326,
2014 Oct.
8. J Cell Mol Med 12(1):227–240, 2008.
Retraction in: J Cell Mol Med
19(10):2512, 2015 Oct.
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, or recklessly falsifying data
that were included in: J Reprod
Immunol 73(2):118–29, 2007 (hereafter
referred to as ‘‘JRI 2007’’). Specifically,
ORI found that Respondent falsified
data points and standard errors of the
mean in bar graphs plotting matrix
metalloprotease expression or activity in
the following figures of JRI 2007:
• Figures 2A, 2B, 2C
• Figures 3A, 3B, 3C
• Figure 4B
• Figure 5C
• Figure 6B
• Figures 7A, 7B, 7C
• Figure 8, middle left panel and lower
right panel
Dr. Chegini entered into a Voluntary
Settlement Agreement with ORI, in
which he voluntarily agreed to the
following, beginning on July 12, 2017:
(1) Respondent has not applied for or
engaged in U.S. Public Health Service
(PHS)-supported research since 2012;
Respondent has no intention of
applying for or engaging in PHSsupported research or otherwise
VerDate Sep<11>2014
16:35 Aug 02, 2017
Jkt 241001
working with PHS; however, if within
five (5) years of the effective date of the
Agreement, the Respondent receives or
applies for PHS support, the
Respondent agreed to have his research
supervised for a period of five (5) years
from the date of his employment in a
position in which he receives or applies
for PHS support and agreed to notify his
employer(s)/institution(s) of the terms of
this supervision; Respondent agreed
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 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;
(2) Respondent agreed that for a
period of five (5) years beginning on the
date on which the Respondent receives
or applies for PHS support, 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;
(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 five (5)
years, beginning with the effective date
of the Agreement; and
(4) as a condition of the Agreement,
Respondent will request that J Reprod
Immunol 73(2):118–29, 2007 be
retracted.
FOR FURTHER INFORMATION CONTACT:
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8200.
Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2017–16311 Filed 8–2–17; 8:45 am]
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36151
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel NIAID Clinical Trial
Implementation Grant (R01).
Date: August 28, 2017.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Kelly Y. Poe, Ph.D.,
Scientific Review Program, Division of
Extramural Activities, Room 3F40B National
Institutes of Health, NIAID, 5601 Fishers
Lane, MSC 9823, Bethesda, MD 20892–9823,
(240) 669–5036, poeky@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 28, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–16314 Filed 8–2–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
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]]>Agencies
[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Pages 36150-36151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16311]
-----------------------------------------------------------------------
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:
Nasser Chegini, Ph.D., University of Florida: Based on the report
of an investigation conducted by the University of Florida (UF), the
prior
[[Page 36151]]
corrections in the scientific record noted below, and additional
analysis conducted by ORI in its oversight review, ORI found that Dr.
Nasser Chegini, retired as a Professor in the Department of Obstetrics
and Gynecology, UF, engaged in research misconduct in research
supported by National Institute of Child Health and Human Development
(NICHD), National Institutes of Health (NIH), grant 2 R01 HD037432.
ORI acknowledges that the following papers were retracted as a
result of the institution's investigation:
1. J Clin Endocrinol Metab 88(10):4967-4976, 2003. Retraction in: J
Clin Endocrinol Metab 100(1):318, 2015 Jan.
2. Reprod Biol Endocrinol 1:125, 2003. Retraction in: Reprod Biol
Endocrinol 13:25, 2015 Apr 3.
3. J Clin Endocrinol Metab 88(3):1350-1361, 2003. Retraction in: J
Clin Endocrinol Metab 100(1):318, 2015 Jan.
4. Hum Reprod 21(10):2555-2563, 2006. Retraction in: Hum Reprod
30(1):249, 2015 Jan (Epub 2014 Nov 6).
5. Mol Hum Reprod 12(4):245-256, 2006. Retraction in: Mol Hum Reprod
20(12):1258, 2014 Dec (Epub 2014 Nov 13).
6. Mol Hum Reprod 13(11):797-806, 2007. Retraction in: Mol Hum
Reprod 20(12):1259, 2014 Dec (Epub 2014 Nov 13).
7. Reprod Sci 15(10):993-1001, 2007. Retraction in: Reprod Sci
21(10):1326, 2014 Oct.
8. J Cell Mol Med 12(1):227-240, 2008. Retraction in: J Cell Mol Med
19(10):2512, 2015 Oct.
ORI found that Respondent engaged in research misconduct by
intentionally, knowingly, or recklessly falsifying data that were
included in: J Reprod Immunol 73(2):118-29, 2007 (hereafter referred to
as ``JRI 2007''). Specifically, ORI found that Respondent falsified
data points and standard errors of the mean in bar graphs plotting
matrix metalloprotease expression or activity in the following figures
of JRI 2007:
Figures 2A, 2B, 2C
Figures 3A, 3B, 3C
Figure 4B
Figure 5C
Figure 6B
Figures 7A, 7B, 7C
Figure 8, middle left panel and lower right panel
Dr. Chegini entered into a Voluntary Settlement Agreement with ORI,
in which he voluntarily agreed to the following, beginning on July 12,
2017:
(1) Respondent has not applied for or engaged in U.S. Public Health
Service (PHS)-supported research since 2012; Respondent has no
intention of applying for or engaging in PHS-supported research or
otherwise working with PHS; however, if within five (5) years of the
effective date of the Agreement, the Respondent receives or applies for
PHS support, the Respondent agreed to have his research supervised for
a period of five (5) years from the date of his employment in a
position in which he receives or applies for PHS support and agreed to
notify his employer(s)/institution(s) of the terms of this supervision;
Respondent agreed 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
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;
(2) Respondent agreed that for a period of five (5) years beginning
on the date on which the Respondent receives or applies for PHS
support, 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;
(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 five (5) years, beginning with the effective
date of the Agreement; and
(4) as a condition of the Agreement, Respondent will request that J
Reprod Immunol 73(2):118-29, 2007 be retracted.
FOR FURTHER INFORMATION CONTACT: Director, Office of Research
Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240)
453-8200.
Kathryn M. Partin,
Director, Office of Research Integrity.
[FR Doc. 2017-16311 Filed 8-2-17; 8:45 am]
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