Findings of Research Misconduct, 77467-77468 [2013-30424]
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Federal Register / Vol. 78, No. 246 / Monday, December 23, 2013 / Notices
Form is designed to collect data from
health care providers who have
requested certification to participate in
the Medicare Part A program. As part of
the Medicare certification process,
health care facilities must receive a civil
rights clearance from the Office for Civil
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to determine compliance with civil
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rights information is requested only
when a health care provider applies for
Medicare Part A certification; it is not
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Entities that are affected by the Civil
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health care providers applying for
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who, as a result of civil rights
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reviews are requested when health care
providers, such as hospitals, nursing
homes and home health agencies, apply
to participate in the Medicare Part A
program. When a provider seeks
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whether the provider will be able to
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the Age Discrimination Act. Such
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Likely Respondents: Healthcare
providers.
Burden Statement: In conducting a
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compliance review was performed by
77467
OCR. In many instances, the procedure
decreases the burden on the recipient
since the compliance review and
corrective actions, as necessary, may
reduce or eliminate the need for a
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Subsequent to such approval, only local
facility-specific information is reviewed
by OCR for civil rights compliance
during the review process.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Form name
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
The Civil Rights Information Request Form ....................................................
2900
1
8
23,200
OS specifically requests comments on
(1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Darius Taylor,
Deputy, Information Collection Clearance
Officer.
[FR Doc. 2013–30467 Filed 12–20–13; 8:45 am]
BILLING CODE 4153–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
tkelley on DSK3SPTVN1PROD with NOTICES
Office of the Secretary
Findings of Research Misconduct
AGENCY:
ACTION:
Office of the Secretary, HHS.
Notice.
Notice is hereby given that
the Office of Research Integrity (ORI)
SUMMARY:
VerDate Mar<15>2010
18:12 Dec 20, 2013
Jkt 232001
has taken final action in the following
case:
Dong-Pyou Han, Ph.D., Iowa State
University of Science and Technology:
Based on the report of an inquiry
conducted by the Iowa State University
of Science and Technology (ISU), a
detailed admission by the Respondent,
and additional analysis conducted by
ORI, ORI and ISU found that Dr. DongPyou Han, former Research Assistant
Professor, Department of Biomedical
Services, ISU, engaged in research
misconduct in research supported by
National Institute of Allergy and
Infectious Diseases (NIAID), National
Institutes of Health (NIH), grants P01
AI074286, R33 AI076083, and U19
AI091031.
ORI and ISU found that the
Respondent falsified results in research
to develop a vaccine against human
immunodeficiency virus-1 (HIV–1) by
intentionally spiking samples of rabbit
sera with antibodies to provide the
desired results. The falsification made it
appear that rabbits immunized with the
gp41–54 moiety of the HIV gp41
glycoprotein induced antibodies capable
of neutralizing a broad range of HIV–1
strains, when the original sera were
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
weakly or non-reactive in neutralization
assays. Falsified neutralization assay
results were widely reported in
laboratory meetings, seven (7) national
and international symposia between
2010 and 2012, and in grant
applications and progress reports P01
AI074286–03, ¥04, ¥05, and ¥06; R33
AI076083–04; U19 AI091031–01 and
¥03; and R01 AI090921–01.
Specifically:
a. Respondent falsified research
materials when he provided
collaborators with sera for
neutralization assays from (i) rabbits
immunized with peptides from HIV
gp41–54Q (and related antigens HR1–
54Q, gp41–54Q–OG, gp41–54Q–GHC,
gp41–54Q-Cys and Cys-gp41–54Q) to
assay HIV neutralizing activity, when
Respondent had spiked the samples
with human IgG known to contain
broadly neutralizing antibodies to HIV–
1; and (ii) rabbits immunized with HIV
gp41–54Q to assay HIV neutralizing
activity, when Respondent had spiked
the samples with sera from rabbits
immunized with HIV–1 gp120 that
neutralized HIV.
b. Respondent falsified data files for
neutralization assays, and provided
E:\FR\FM\23DEN1.SGM
23DEN1
77468
Federal Register / Vol. 78, No. 246 / Monday, December 23, 2013 / Notices
false data to his laboratory colleagues, to
make it appear that rabbits immunized
with gp41–54Q and recombinant
Lactobacillus expressing gp41–64 (LAB
gp41–64) produced broadly reactive
neutralizing antibodies, by changing the
numbers to show that samples with
little or no neutralizing activity had
high activity.
Dr. Han has entered into a Voluntary
Exclusion Agreement and has
voluntarily agreed for a period of three
(3) years, beginning on November 25,
2013:
(1) To exclude himself 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 et
seq) of OMB Guidelines to Agencies on
Governmentwide Debarment and
Suspension, 2 CFR Part 180 (collectively
the ‘‘Debarment Regulations’’); and
(2) to exclude himself voluntarily
from serving in any advisory capacity to
the U.S. Public Health Service (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) 453–8800.
approval to conduct courses, and if
approved, notification to NIOSH of any
course or faculty changes during the
approval period, which is limited to five
years. The application form and added
materials, including an agenda,
curriculum vitae, and course materials
are reviewed by NIOSH to determine if
the applicant has developed a program
which adheres to the criteria required in
the standard. Following approval, any
subsequent changes to the course are
submitted by course sponsors via letter
or email and reviewed by NIOSH staff
to assure that the changes in faculty or
course content continue to meet course
requirements. Course sponsors also
voluntarily submit an annual report to
inform NIOSH of their class activity
level and any faculty changes. Sponsors
who elect to have their approval
renewed for an additional 5 year period
submit a renewal application and
supporting documentation for review by
NIOSH staff to ensure the course
curriculum meets all current standard
requirements.
Approved courses that elect to offer
NIOSH-Approved Spirometry Refresher
Courses must submit a separate
application and supporting documents
for review by NIOSH staff. Institutions
and organizations throughout the
country voluntarily submit applications
and materials to become course
sponsors and carry out training.
Submissions are required for NIOSH to
evaluate a course and determine
whether it meets the criteria in the
standard and whether technicians will
be adequately trained as mandated
under the standard. NIOSH will
disseminate a one-time customer
satisfaction survey to course directors
and sponsor representatives to evaluate
our service to courses, the effectiveness
of the program changes implemented
since 2005, and the usefulness of
potential Program enhancements.
The annualized figures slightly overestimate the actual burden, due to
rounding of the number of respondents
for even allocation over the three-year
clearance period. The estimated annual
burden to respondents is 201 hours.
There will be no cost to respondents.
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to LeRoy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
David E. Wright,
Director, Office of Research Integrity.
Pulmonary Function Testing Course
Approval Program, 29 CFR 1910.1043
(OMB No. 0920–0138, Expiration 8/31/
2014)—Revision—The National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
[FR Doc. 2013–30424 Filed 12–20–13; 8:45 am]
Background and Brief Description
BILLING CODE 4150–31–P
NIOSH has the responsibility under
the Occupational Safety and Health
Administration’s Cotton Dust Standard,
29 CFR 1920.1043, for approving
courses to train technicians to perform
pulmonary function testing in the cotton
industry. Successful completion of a
NIOSH-approved course is mandatory
under the standard.
To carry out its responsibility, NIOSH
maintains a Pulmonary Function
Testing Course Approval Program. The
program consists of an application
submitted by potential sponsors
(universities, hospitals, and private
consulting firms) who seek NIOSH
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60-Day 14–0138]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
tkelley on DSK3SPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
No. of
respondents
Type of respondents
Form name
Potential Sponsors ............................
Initial Application ..............................
Annual Report ..................................
Report for Course Changes .............
Renewal Application .........................
VerDate Mar<15>2010
18:12 Dec 20, 2013
Jkt 232001
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
No. of
responses per
respondent
3
35
12
13
E:\FR\FM\23DEN1.SGM
1
1
1
1
23DEN1
Average
burden per
response
(in hours)
3.5
30/60
45/60
6
Total burden
(in hours)
11
18
9
78
]]>Agencies
[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Notices]
[Pages 77467-77468]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30424]
-----------------------------------------------------------------------
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:
Dong-Pyou Han, Ph.D., Iowa State University of Science and
Technology: Based on the report of an inquiry conducted by the Iowa
State University of Science and Technology (ISU), a detailed admission
by the Respondent, and additional analysis conducted by ORI, ORI and
ISU found that Dr. Dong-Pyou Han, former Research Assistant Professor,
Department of Biomedical Services, ISU, engaged in research misconduct
in research supported by National Institute of Allergy and Infectious
Diseases (NIAID), National Institutes of Health (NIH), grants P01
AI074286, R33 AI076083, and U19 AI091031.
ORI and ISU found that the Respondent falsified results in research
to develop a vaccine against human immunodeficiency virus-1 (HIV-1) by
intentionally spiking samples of rabbit sera with antibodies to provide
the desired results. The falsification made it appear that rabbits
immunized with the gp41-54 moiety of the HIV gp41 glycoprotein induced
antibodies capable of neutralizing a broad range of HIV-1 strains, when
the original sera were weakly or non-reactive in neutralization assays.
Falsified neutralization assay results were widely reported in
laboratory meetings, seven (7) national and international symposia
between 2010 and 2012, and in grant applications and progress reports
P01 AI074286-03, -04, -05, and -06; R33 AI076083-04; U19 AI091031-01
and -03; and R01 AI090921-01. Specifically:
a. Respondent falsified research materials when he provided
collaborators with sera for neutralization assays from (i) rabbits
immunized with peptides from HIV gp41-54Q (and related antigens HR1-
54Q, gp41-54Q-OG, gp41-54Q-GHC, gp41-54Q-Cys and Cys-gp41-54Q) to assay
HIV neutralizing activity, when Respondent had spiked the samples with
human IgG known to contain broadly neutralizing antibodies to HIV-1;
and (ii) rabbits immunized with HIV gp41-54Q to assay HIV neutralizing
activity, when Respondent had spiked the samples with sera from rabbits
immunized with HIV-1 gp120 that neutralized HIV.
b. Respondent falsified data files for neutralization assays, and
provided
[[Page 77468]]
false data to his laboratory colleagues, to make it appear that rabbits
immunized with gp41-54Q and recombinant Lactobacillus expressing gp41-
64 (LAB gp41-64) produced broadly reactive neutralizing antibodies, by
changing the numbers to show that samples with little or no
neutralizing activity had high activity.
Dr. Han has entered into a Voluntary Exclusion Agreement and has
voluntarily agreed for a period of three (3) years, beginning on
November 25, 2013:
(1) To exclude himself 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 et seq) of OMB Guidelines to Agencies on Governmentwide
Debarment and Suspension, 2 CFR Part 180 (collectively the ``Debarment
Regulations''); and
(2) to exclude himself voluntarily from serving in any advisory
capacity to the U.S. Public Health Service (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)
453-8800.
David E. Wright,
Director, Office of Research Integrity.
[FR Doc. 2013-30424 Filed 12-20-13; 8:45 am]
BILLING CODE 4150-31-P
