Findings of Research Misconduct, 39530-39531 [2010-16824]
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39530
Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices
President Freight Forwarding
(Qualifying Individual), Kim Kyung
Bae, CEO, Application Type: QI
Change
Golden Freight, Inc. dba Saigon Express
(OFF & NVO), 510 Parrott Street, #2,
San Jose, CA 95112. Officer: Chi T.
Hoang, CEO/CFO/Secretary
(Qualifying Individual), Application
Type: Add NVO Service
Grupo Tical Holding, Inc. dba GTH
Corporation (OFF & NVO), 7701 NW.
46th Street, Doral, FL 33166. Officers:
Albert Oses, Secretary/Treasurer
(Qualifying Individual), Luis A.
Ramirez, President, Application Type:
New OFF & NVO License
Interport Logistics, LLC (OFF & NVO),
2000 NW. 84th Avenue, Doral, FL
33122. Officer: Alberto J. Marino,
Manager (Qualifying Individual),
Application Type: Business Structure
Change
International Logistic Services, Inc.
(OFF & NVO), 155–11 146th Avenue,
Jamaica, NY 11434. Officers: Cora R.
Fong, Vice President (Qualifying
Individual), Jean P. Noens, President/
Secretary/Treasurer, Application
Type: QI Change
JWJ Express Inc. (OFF & NVO), 149–23
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11413. Officers: Charles Wu, Vice
President/Secretary (Qualifying
Individual), Saughwan Lee, President/
Treasurer, Application Type: QI
Change
Login Logistics USA, Corp. (NVO), 1345
NW. 98th Court, Bldg. A, Unit 9,
Doral, FL 33172. Officers: William
Medina, Director/Secretary
(Qualifying Individual), Rodinilson B.
da Silva, Director/President,
Application Type: New NVO License
M.O.T. Intermodal Shipping USA, Inc.
(OFF & NVO), 1200–C Scottsville
Road, Rochester, NY 14624. Officers:
Danielle M. Hogancamp, Vice
President/Secretary (Qualifying
Individual), Ole Enderslev, President/
Treasurer, Application Type: Add
NVO Service
Net Cargo LLC (OFF & NVO), 9619 NW.
33rd Street, Doral, FL 33178. Officers:
Victor E. Segura/General Manager
Member/Treasurer (Qualifying
Individual), Jorge A. Paez, Manager
Member/Secretary, Application Type:
New OFF & NVO License
Overseas Cargo Inc. (OFF & NVO), 332
S. Wayside Drive, Houston, TX 77011.
Officer: Mohammed S. Mohamed,
CEO (Qualifying Individual),
Application Type: New OFF & NVO
License
Pacific Republic West Inc. (OFF &
NVO), 420 McKinley Street, Suite
111–209, Corona, CA 92879. Officer:
Haiying L. Snider, Secretary
VerDate Mar<15>2010
15:17 Jul 08, 2010
Jkt 220001
(Qualifying Individual), Application
Type: New OFF & NVO License
Pactrans Global, LLC (OFF & NVO), 950
Thorndale Avenue, Elk Grove Village,
IL 60007. Officers: Chance Pon,
Managing Member (Qualifying
Individual), Kitty Pon, Manager,
Application Type: New OFF & NVO
License
Skylink Global Logistics, Inc. (OFF &
NVO), One Industrial Plaza, Bldg. C,
Valley Stream, NY 11581. Officers:
Toru Mizuno, Vice President/
Secretary (Qualifying Individual),
Kevin Connolly, President/Treasurer,
Application Type: New OFF & NVO
License
Shipping Solutions Worldwide, Ltd.
(OFF & NVO), 14650 Rothgeb Drive,
Unit P, Rockville, MD 20850. Officers:
Raul Zambrano, Vice President
(Qualifying Individual), Edgar
Zambrano, President, Application
Type: New OFF & NVO
Talwin Transport Service LLC (OFF &
NVO), 8305 NW. 27th Street, Suite
111, Doral, FL 33122. Officers: Orestes
G. Wrves, Secretary/Treasurer/MGRM
(Qualifying Individual), Gabriel N.
Taberna, President/MGRM,
Application Type: New OFF & NVO
Transoceanic Projects Development
Company, Inc. dba AKL Shipping,
Company (OFF & NVO), 1801
Kingwood Drive, Suite 270,
Kingwood, TX 77339. Officers:
Richard W. Castaing, Executive Vice
President (Qualifying Individual),
Arval D. Headrick, Sr., President,
Application Type: New OFF & NVO
License
Transworld Logistics & Shipping
Services, Inc. dba All Cargo, Movers
Inc. dba Balaji Shipping (U.K.)
Limited dba TLSS, Inc. (OFF & NVO),
200 Middlesex Essex Turnpike, Suite
200, Iselin, NJ 08830. Officers: Allan
J. Couto, Vice President (Qualifying
Individual), Sivaswamy I.
Ramakrishnan, President, Application
Type: Add NVO Service/Trade Name
Change
Viva Logistics Inc. (OFF & NVO), 347
Fifth Avenue, #910, New York, NY
10016. Officers: Shao F. Lai, Vice
President (Qualifying Individual),
Wheiyu Wang, President, Application
Type: New OFF & NVO License
Dated: July 2, 2010.
Karen V. Gregory,
Secretary.
[FR Doc. 2010–16734 Filed 7–8–10; 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)
and the Assistant Secretary for Health
have taken final action in the following
case:
Gerardo L. Paez, PhD, University of
Pennsylvania: Based on the reports of an
inquiry and an investigation conducted
by the University of Pennsylvania (UP)
and analysis conducted by the ORI
Division of Investigative Oversight
(DIO), ORI found that Gerardo L. Paez,
PhD, former postdoctoral fellow,
Section of Medical Genetics, UP School
of Veterinary Medicine, engaged in
research misconduct in research
supported by National Eye Institute
(NEI), National Institutes of Health
(NIH), awards R01 EY06855 and R01
EY13132.
ORI found that the Respondent
engaged in research misconduct by
falsifying and fabricating retinal gene
profile data that he purportedly
obtained from three-week old normal
dogs and dogs with X-linked progressive
retinal atrophy.
Specifically, ORI found that:
1. Respondent committed research
misconduct by falsifying/fabricating
data for gene expression profiles in
retinal tissue from three-week old
normal dogs and dogs with X-linked
progressive retinal atrophy in abstracts
and poster presentations for the 2006 1
and 2007 2 Association for Research in
Vision and Ophthalmology (ARVO)
meetings and in an unsubmitted
manuscript draft.3
2. Respondent falsely labeled data
files in the UP bioinformatics core
computer and submitted falsely
identified files to his research mentors.
Dr. Paez has entered into a Voluntary
Settlement Agreement in which he has
voluntarily agreed, for a period of three
(3) years, beginning on June 9, 2010:
(1) To exclude himself from serving in
any advisory capacity to PHS, including
1 Paez, G.L., Zangerl, B., Acland, G.M., & Aguirre,
G.D. ‘‘Abnormal gene expression profile in retinas
with RPGR frameshift mutation.’’
2 Paez, G.L., Zangerl, B., Acland, G.M., & Aguirre,
G.D. ‘‘Photoreceptor degeneration and tumor
suppressor gene expression in canine retinas with
RGR frameshift mutation.’’
3 Paez, G.L., Zangerl, B., Acland, G.M., & Aguirre,
G.D. ‘‘Age-related changes in the transcriptional
profile of normal and XLPRAII retinas using a
custom cDNA microarray.’’
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Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Notices
but not limited to service on any PHS
advisory committee, board, and/or peer
review committee, or as a consultant;
(2) that any institution that submits an
application for PHS support for a
research project on which the
Respondent’s participation is proposed
or that uses him in any capacity on
PHS-supported research, or that submits
a report of PHS-funded research in
which he is involved, must concurrently
submit a plan for supervision of his
duties to the funding agency for
approval; the supervisory plan must be
designed to ensure the scientific
integrity of his research contribution. A
copy of the supervisory plan also must
be submitted to ORI by the institution.
Respondent agreed that he will not
participate in any PHS-supported
research until such a supervisory plan is
submitted to ORI.
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. 2010–16824 Filed 7–8–10; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
BILLING CODE 4151–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Name: National Committee on Vital and
Health Statistics (NCVHS) Standards
Subcommittee.
Time and Date: July 19, 2010 9 a.m.–5 p.m.
July 20, 2010 8:30 a.m.–5 p.m. July 21, 2010
9 a.m.–5 p.m. (committee discussion)
Place: Hamilton Crowne Plaza Hotel, 1001
14th Street, NW., Washington, DC 20005,
(202) 682–0111.
Status: Open.
Purpose: The purpose of this upcoming
meeting of the Subcommittee on Standards is
to receive industry input on a unique health
plan identifier to be used in HIPAA standard
transactions, and on new operating rules for
standards, and their authoring organizations.
The Subcommittee will hear testimony from
individuals, organizations and associations
on these matters. The subcommittee will
meet for three consecutive days for which a
variety of panels are scheduled; day one will
focus on the unique health plan identifier,
day two will concentrate on authoring
organizations and operating rules for
eligibility and health claim status, and day
15:17 Jul 08, 2010
Jkt 220001
Dated: June 29, 2010.
James Scanlon,
Deputy Assistant Secretary for Planning and
Evaluation, Science and Data Policy, Office
of the Assistant Secretary for Planning and
Evaluation.
[FR Doc. 2010–16729 Filed 7–8–10; 8:45 am]
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
VerDate Mar<15>2010
three of the meeting will be reserved for
Subcommittee discussion and deliberation.
The NCVHS has been named in the Patient
Protection and Affordable Care Act (ACA) of
2010 to review and make recommendations
on several HIPAA standards and electronic
transactions. This meeting will support these
activities in the development of a set of
recommendations for the Secretary, as
required by section 1104 of the ACA. Text of
the ACA can be found at https://
dpc.senate.gov/dpcdocsen_health_care_bill.cfm.
Contact Person For More Information:
Substantive program information as well as
summaries of meetings and a roster of
committee members may be obtained from
Lorraine Doo, lead staff for the Standards
Subcommittee, NCVHS, Centers for Medicare
and Medicaid Services, Office of E-Health
Standards and Services, 7500 Security
Boulevard, Baltimore, Maryland, 21244,
telephone (410) 786–6597 or Marjorie S.
Greenberg, Executive Secretary, NCVHS,
National Center for Health Statistics, Centers
for Disease Control and Prevention, 3311
Toledo Road, Room 2402, Hyattsville,
Maryland 20782, telephone (301) 458–4245.
Information also is available on the NCVHS
home page of the HHS Web site: https://
www.ncvhs.hhs.gov/, where further
information including an agenda will be
posted when available.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment Opportunity on
(301) 458–4EEO (4336) as soon as possible.
Food and Drug Administration
[Docket No. FDA–2010–N–0174]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Applications for
Food and Drug Administration
Approval to Market a New Drug: Patent
Submission and Listing Requirements
and Application of 30-Month Stays on
Approval of Abbreviated New Drug
Applications Certifying That a Patent
Claiming a Drug Is Invalid or Will Not
Be Infringed
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
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39531
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by August 9,
2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0513. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Applications for FDA Approval to
Market a New Drug: Patent Submission
and Listing Requirements and
Application of 30-Month Stays on
Approval of Abbreviated New Drug
Applications Certifying That a Patent
Claiming a Drug Is Invalid or Will Not
Be Infringed—OMB Control Number
0910–0513—Extension
Section 505(b)(1) of the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 355(b)(1)) requires all new drug
application (NDA) applicants to file, as
part of the NDA, ‘‘the patent number and
the expiration date of any patent which
claims the drug for which the applicant
submitted the application or which
claims a method of using such drug and
with respect to which a claim of patent
infringement could reasonably be
asserted if a person not licensed by the
owner engaged in the manufacture[,]
use, or sale of the drug.’’ Section
505(c)(2) of the act imposes a similar
patent submission obligation on holders
of approved NDAs when the NDA
holder could not have submitted the
patent information with its application.
Under section 505(b)(1) of the act, we
publish patent information after
approval of an NDA in the list entitled
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations’’
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]]>Agencies
[Federal Register Volume 75, Number 131 (Friday, July 9, 2010)]
[Notices]
[Pages 39530-39531]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16824]
=======================================================================
-----------------------------------------------------------------------
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) and the Assistant Secretary for Health have taken final action in
the following case:
Gerardo L. Paez, PhD, University of Pennsylvania: Based on the
reports of an inquiry and an investigation conducted by the University
of Pennsylvania (UP) and analysis conducted by the ORI Division of
Investigative Oversight (DIO), ORI found that Gerardo L. Paez, PhD,
former postdoctoral fellow, Section of Medical Genetics, UP School of
Veterinary Medicine, engaged in research misconduct in research
supported by National Eye Institute (NEI), National Institutes of
Health (NIH), awards R01 EY06855 and R01 EY13132.
ORI found that the Respondent engaged in research misconduct by
falsifying and fabricating retinal gene profile data that he
purportedly obtained from three-week old normal dogs and dogs with X-
linked progressive retinal atrophy.
Specifically, ORI found that:
1. Respondent committed research misconduct by falsifying/
fabricating data for gene expression profiles in retinal tissue from
three-week old normal dogs and dogs with X-linked progressive retinal
atrophy in abstracts and poster presentations for the 2006 \1\ and 2007
\2\ Association for Research in Vision and Ophthalmology (ARVO)
meetings and in an unsubmitted manuscript draft.\3\
---------------------------------------------------------------------------
\1\ Paez, G.L., Zangerl, B., Acland, G.M., & Aguirre, G.D.
``Abnormal gene expression profile in retinas with RPGR frameshift
mutation.''
\2\ Paez, G.L., Zangerl, B., Acland, G.M., & Aguirre, G.D.
``Photoreceptor degeneration and tumor suppressor gene expression in
canine retinas with RGR frameshift mutation.''
\3\ Paez, G.L., Zangerl, B., Acland, G.M., & Aguirre, G.D.
``Age-related changes in the transcriptional profile of normal and
XLPRAII retinas using a custom cDNA microarray.''
---------------------------------------------------------------------------
2. Respondent falsely labeled data files in the UP bioinformatics
core computer and submitted falsely identified files to his research
mentors.
Dr. Paez has entered into a Voluntary Settlement Agreement in which
he has voluntarily agreed, for a period of three (3) years, beginning
on June 9, 2010:
(1) To exclude himself from serving in any advisory capacity to
PHS, including
[[Page 39531]]
but not limited to service on any PHS advisory committee, board, and/or
peer review committee, or as a consultant;
(2) that any institution that submits an application for PHS
support for a research project on which the Respondent's participation
is proposed or that uses him in any capacity on PHS-supported research,
or that submits a report of PHS-funded research in which he is
involved, must concurrently submit a plan for supervision of his duties
to the funding agency for approval; the supervisory plan must be
designed to ensure the scientific integrity of his research
contribution. A copy of the supervisory plan also must be submitted to
ORI by the institution. Respondent agreed that he will not participate
in any PHS-supported research until such a supervisory plan is
submitted to ORI.
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. 2010-16824 Filed 7-8-10; 8:45 am]
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