Findings of Misconduct in Science, 45056-45057 [E6-12857]
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Federal Register / Vol. 71, No. 152 / Tuesday, August 8, 2006 / Notices
scope of the proposed project and
funding level that conforms to the
project’s stated goals and objectives. The
evaluation plan should include both a
process evaluation to track the
implementation of project activities and
an outcome evaluation to measure
changes in knowledge and skills that
can be attributed to the project. Project
funds may be used to support
evaluation activities. In addition to
conducting their own evaluation of
projects, the successful applicant must
be prepared to participate in an external
evaluation, to be supported by ODPHP/
HHS and conducted by an independent
entity, to assess efficiency and
effectiveness for the project funded
under this announcement.
Within 30 days following the end of
each of quarter, a performance report no
more than ten pages in length must be
submitted to ODPHP/HHS. A sample
monthly performance report will be
provided at the time of notification of
award. At a minimum, monthly
performance reports should include:
• Concise summary of the most
significant achievements and problems
encountered during the reporting
period, e.g. number of training courses
held and number of trainees.
• A comparison of work progress
with objectives established for the
quarter using the grantee’s
implementation schedule, and where
such objectives were not met, a
statement of why they were not met.
• Specific action(s) that the grantee
would like the ODPHP/HHS to
undertake to alleviate a problem.
• Other pertinent information that
will permit monitoring and overview of
project operations.
• A quarterly financial report
describing the current financial status of
the funds used under this award. The
awardee and ODPHP will agree at the
time of award for the format of this
portion of the report.
Within 90 days following the end of
the project period a final report
containing information and data of
interest to HHS must be submitted to
ODPHP/HHS. The specifics as to the
format and content of the final report
and the summary will be sent to the
successful applicant. At minimum, the
report should contain:
• A summary of the major activities
supported under the agreement and the
major accomplishments resulting from
activities with the potential for
improving the health of children in
Arkansas and its potential for
generalizability to other States and
communities.
• An analysis of the project based on
the problem(s) described in the
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application and needs assessments,
performed prior to or during the project
period, including a description of the
specific objectives stated in the grant
application and the accomplishments
and failures resulting from activities
during the grant period.
Quarterly performance reports and
the final report may be submitted to:
Office of Disease Prevention and Health
Promotion, Office of Public Health and
Science, Office of the Secretary
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
LL100, Rockville, Maryland 20852.
A Financial Status Report (FSR) SF–
269 is due 90 days after the close of each
12-month budget period and submitted
to the OPHS-Office of Grants
Management.
VII. Agency Contacts
For programmatic requirements,
please contact: Woodie Kessel, MD,
MPH; Cecilia Penn, MD, MPH; Kathryn
McMurry, MS, Office of Disease
Prevention and Health Promotion,
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
LL100, Rockville, Maryland 20852,
telephone: (240) 453–8256.
For administrative requirements,
please contact: Office of Grants
Management, Office of Public Health
and Science, Department of Health and
Human Services, 1101 Wootton
Parkway, Suite 550, Rockville,
Maryland 20852, telephone: (240) 453–
8822.
VIII. Tips for Writing a Strong
Application
Include DUNS Number. You must
include a DUNS Number to have your
application reviewed. To obtain a DUNS
number, access
www.dunandbradstreet.com or call 1–
866–705–5711. Please include the
DUNS number next to the OMB
Approval Number on the application
face page.
Keep your audience in mind.
Reviewers will use only the information
contained in the application to assess
the application. Be sure the application
and responses to the program
requirements and expectations are
complete and clearly written. Do not
assume that reviewers are familiar with
the applicant organization. Keep the
review criteria in mind when writing
the application.
Start preparing the application early.
Allow plenty of time to gather required
information from various sources.
Follow the instructions in this
guidance carefully. Place all information
in the order requested in the guidance.
If the information is not placed in the
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requested order, you may receive a
lower score.
Be brief, concise, and clear. Make
your points understandable. Provide
accurate and honest information,
including candid accounts of problems
and realistic plans to address them. If
any required information or data is
omitted, explain why. Make sure the
information provided in each table,
chart, attachment, etc., is consistent
with the proposal narrative and
information in other tables.
Be organized and logical. Many
applications fail to receive a high score
because the reviewers cannot follow the
thought process of the applicant or
because parts of the application do not
fit together.
Be careful in the use of appendices.
Do not use the appendices for
information that is required in the body
of the application. Be sure to crossreference all tables and attachments
located in the appendices to the
appropriate text in the application.
Carefully proofread the application.
Misspellings and grammatical errors
will impede reviewers in understanding
the application. Be sure pages are
numbered (including appendices) and
that page limits are followed. Limit the
use of abbreviations and acronyms, and
define each one at its first use and
periodically throughout application.
Dated: July 31, 2006.
Woodie Kessel,
Deputy Director for Medicine and Health
Science, Office of Disease Prevention and
Health Promotion.
[FR Doc. E6–12819 Filed 8–7–06; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Misconduct in Science
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:
Ms. Sylvia Okoro, University of
Maryland at Baltimore: Based on the
University of Maryland at Baltimore
(UMAB) investigation committee report
and additional analysis and information
obtained by ORI during its oversight
review, the U.S. Public Health Service
(PHS) found that Ms. Okoro, former
Research Assistant, UMAB, engaged in
misconduct in science by fabricating
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Federal Register / Vol. 71, No. 152 / Tuesday, August 8, 2006 / Notices
and falsifying patient data in research
supported by National Institute on
Aging (NIA), National Institutes of
Health (NIH), grant R01 AG18461.
Specifically, Ms. Okoro intentionally
and knowingly fabricated and falsified
data for six visit dates on one patient
data form and falsified and fabricated
patient condition information on two
additional study subjects by failing to
note that each patient had experienced
a fall as documented in their medical
charts.
ORI has implemented the following
administrative actions for a period of
three (3) years, beginning July 17, 2006:
(1) Ms. Okoro is prohibited 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; and
(2) Any institution that submits an
application for PHS support for a
research project on which Ms. Okoro’s
participation is proposed or which uses
her services in any capacity on PHS
supported research must concurrently
submit a plan for supervision of her
duties. The supervisory plan must be
designed to ensure the scientific
integrity of Ms. Okoro’s research
contribution and must be submitted to
ORI by the institution.
FOR FURTHER INFORMATION CONTACT:
Director, Division of Investigative
Oversight, Office of Research Integrity,
1101 Wootton Parkway, Suite 750,
Rockville, MD 20852, (240) 453–8800.
Chris B. Pascal, J.D.,
Director, Office of Research Integrity.
[FR Doc. E6–12857 Filed 8–7–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Science Advisory Board to the
National Center for Toxicological
Research; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Science
Advisory Board (SAB) to the National
Center for Toxicological Research
(NCTR).
General Function of the Committee:
The Board advises the Director, NCTR,
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in establishing, implementing, and
evaluating the research programs that
assist the Commissioner of Food and
Drugs in fulfilling his regulatory
responsibilities. The Board provides an
extra-agency review in ensuring that the
research programs at NCTR are
scientifically sound and pertinent.
Date and Time: The meeting will be
held on August 29, 2006 from 8:30 a.m.
to 4:30 p.m. and on August 30, 2006,
from 8 a.m. to 12 noon.
Location: August 29, 2006: NCTR SAB
Conference Room B–12, 3900 NCTR Dr.,
Jefferson, AR 72079. August 30, 2006:
University of Arkansas for Medical
Sciences, Stephens Spine Center,
Hamlin Board Room, 501 Jack Stephens
Dr., Little Rock, AR 72205.
Contact Person: Leonard Schechtman,
Executive Secretary, National Center for
Toxicological Research, Food and Drug
Administration, 5600 Fishers Lane, rm.
16–85, Rockville, MD 20857, 301–827–
6696, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area), code 3014512559. Please call the
Information Line for up-to-date
information on this meeting.
Agenda: On August 29, 2006, the SAB
will hear presentations from the NCTR
Divisions that will update them on
ongoing research activities. The SAB
will be presented with a response to the
evaluation of the Division of
Neurotoxicology. The evaluation was
the product of a site visit team that
conducted an on-site review of the
Division in January 2004. The response
will address the issues raised and
recommendations made by the site visit
team. On August 30, 2006, the NCTR
Director will provide a Center-wide
update on scientific endeavors and will
discuss the NCTR realignment and
strategic focus.
Procedure: On August 29, 2006, from
8:30 a.m. to 4:30 p.m., and August 30,
2006, from 8 a.m. to 10:30 a.m., the
meeting is open to the public. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the committee. Written
submissions may be made to the contact
person on or before August 14, 2006.
Oral presentations from the public will
be scheduled on August 29, 2006,
between approximately 12:30 p.m. to
1:30 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should likewise notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
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45057
requested to make their presentation on
or before August 14, 2006.
Closed Committee Deliberations: On
August 29, 2006, from approximately 11
a.m. to 12:30 p.m., the meeting will be
closed to permit discussion where
disclosure would constitute a clearly
unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). This
portion of the meeting will be closed to
permit discussion of information
concerning individuals associated with
the research programs at NCTR.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact the office of
the Executive Secretary at least 7 days
in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–12863 Filed 8–7–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1992S–0251] (formerly 92S–
0251)
Food and Drug Administration
Electronic Submissions Gateway
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the FDA Electronic
Submissions Gateway (ESG) for the
receipt and processing of electronic
submissions provided so that the Center
for Biologics Evaluation and Research
(CBER), the Center for Drug Evaluation
and Research (CDER), and the Center for
Devices and Radiological Health (CDRH)
can receive regulatory submissions
electronically. The FDA ESG enables
applicants to send applications and
other submissions for review using the
Internet, provides a single point of entry
for these submissions, and fulfills goals
identified in the Prescription Drug User
Fee Act (PDUFA III).
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Agencies
[Federal Register Volume 71, Number 152 (Tuesday, August 8, 2006)]
[Notices]
[Pages 45056-45057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12857]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Findings of Misconduct in Science
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:
Ms. Sylvia Okoro, University of Maryland at Baltimore: Based on the
University of Maryland at Baltimore (UMAB) investigation committee
report and additional analysis and information obtained by ORI during
its oversight review, the U.S. Public Health Service (PHS) found that
Ms. Okoro, former Research Assistant, UMAB, engaged in misconduct in
science by fabricating
[[Page 45057]]
and falsifying patient data in research supported by National Institute
on Aging (NIA), National Institutes of Health (NIH), grant R01 AG18461.
Specifically, Ms. Okoro intentionally and knowingly fabricated and
falsified data for six visit dates on one patient data form and
falsified and fabricated patient condition information on two
additional study subjects by failing to note that each patient had
experienced a fall as documented in their medical charts.
ORI has implemented the following administrative actions for a
period of three (3) years, beginning July 17, 2006:
(1) Ms. Okoro is prohibited 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; and
(2) Any institution that submits an application for PHS support for
a research project on which Ms. Okoro's participation is proposed or
which uses her services in any capacity on PHS supported research must
concurrently submit a plan for supervision of her duties. The
supervisory plan must be designed to ensure the scientific integrity of
Ms. Okoro's research contribution and must be submitted to ORI by the
institution.
FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative
Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite
750, Rockville, MD 20852, (240) 453-8800.
Chris B. Pascal, J.D.,
Director, Office of Research Integrity.
[FR Doc. E6-12857 Filed 8-7-06; 8:45 am]
BILLING CODE 4150-31-P