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Federal Register / Vol. 71, No.

152 / Tuesday, August 8, 2006 / Notices 45057

and falsifying patient data in research in establishing, implementing, and requested to make their presentation on
supported by National Institute on evaluating the research programs that or before August 14, 2006.
Aging (NIA), National Institutes of assist the Commissioner of Food and Closed Committee Deliberations: On
Health (NIH), grant R01 AG18461. Drugs in fulfilling his regulatory August 29, 2006, from approximately 11
Specifically, Ms. Okoro intentionally responsibilities. The Board provides an a.m. to 12:30 p.m., the meeting will be
and knowingly fabricated and falsified extra-agency review in ensuring that the closed to permit discussion where
data for six visit dates on one patient research programs at NCTR are disclosure would constitute a clearly
data form and falsified and fabricated scientifically sound and pertinent. unwarranted invasion of personal
patient condition information on two Date and Time: The meeting will be privacy (5 U.S.C. 552b(c)(6)). This
additional study subjects by failing to held on August 29, 2006 from 8:30 a.m. portion of the meeting will be closed to
note that each patient had experienced to 4:30 p.m. and on August 30, 2006, permit discussion of information
a fall as documented in their medical from 8 a.m. to 12 noon. concerning individuals associated with
charts. Location: August 29, 2006: NCTR SAB the research programs at NCTR.
ORI has implemented the following Conference Room B–12, 3900 NCTR Dr., Persons attending FDA’s advisory
administrative actions for a period of Jefferson, AR 72079. August 30, 2006: committee meetings are advised that the
three (3) years, beginning July 17, 2006: University of Arkansas for Medical agency is not responsible for providing
(1) Ms. Okoro is prohibited from Sciences, Stephens Spine Center, access to electrical outlets.
serving in any advisory capacity to PHS, Hamlin Board Room, 501 Jack Stephens FDA welcomes the attendance of the
including but not limited to service on Dr., Little Rock, AR 72205. public at its advisory committee
any PHS advisory committee, board, Contact Person: Leonard Schechtman, meetings and will make every effort to
and/or peer review committee, or as a Executive Secretary, National Center for accommodate persons with physical
consultant; and Toxicological Research, Food and Drug disabilities or special needs. If you
(2) Any institution that submits an Administration, 5600 Fishers Lane, rm. require special accommodations due to
application for PHS support for a 16–85, Rockville, MD 20857, 301–827– a disability, please contact the office of
research project on which Ms. Okoro’s 6696, or FDA Advisory Committee the Executive Secretary at least 7 days
participation is proposed or which uses Information Line, 1–800–741–8138
in advance of the meeting.
her services in any capacity on PHS (301–443–0572 in the Washington, DC
Notice of this meeting is given under
supported research must concurrently area), code 3014512559. Please call the
the Federal Advisory Committee Act (5
submit a plan for supervision of her Information Line for up-to-date
U.S.C. app. 2).
duties. The supervisory plan must be information on this meeting.
designed to ensure the scientific Agenda: On August 29, 2006, the SAB Dated: August 2, 2006.
integrity of Ms. Okoro’s research will hear presentations from the NCTR Jeffrey Shuren,
contribution and must be submitted to Divisions that will update them on Assistant Commissioner for Policy.
ORI by the institution. ongoing research activities. The SAB [FR Doc. E6–12863 Filed 8–7–06; 8:45 am]
will be presented with a response to the BILLING CODE 4160–01–S
Director, Division of Investigative evaluation of the Division of
Oversight, Office of Research Integrity, Neurotoxicology. The evaluation was
the product of a site visit team that DEPARTMENT OF HEALTH AND
1101 Wootton Parkway, Suite 750,
conducted an on-site review of the HUMAN SERVICES
Rockville, MD 20852, (240) 453–8800.
Division in January 2004. The response
Chris B. Pascal, J.D., will address the issues raised and Food and Drug Administration
Director, Office of Research Integrity. recommendations made by the site visit
team. On August 30, 2006, the NCTR [Docket No. 1992S–0251] (formerly 92S–
[FR Doc. E6–12857 Filed 8–7–06; 8:45 am] 0251)
Director will provide a Center-wide
update on scientific endeavors and will Food and Drug Administration
discuss the NCTR realignment and Electronic Submissions Gateway
HUMAN SERVICES Procedure: On August 29, 2006, from AGENCY: Food and Drug Administration,
8:30 a.m. to 4:30 p.m., and August 30, HHS.
Food and Drug Administration 2006, from 8 a.m. to 10:30 a.m., the ACTION: Notice.
meeting is open to the public. Interested
Science Advisory Board to the persons may present data, information, SUMMARY: The Food and Drug
National Center for Toxicological or views, orally or in writing, on issues Administration (FDA) is announcing the
Research; Notice of Meeting pending before the committee. Written availability of the FDA Electronic
AGENCY: Food and Drug Administration, submissions may be made to the contact Submissions Gateway (ESG) for the
HHS. person on or before August 14, 2006. receipt and processing of electronic
Oral presentations from the public will submissions provided so that the Center
ACTION: Notice.
be scheduled on August 29, 2006, for Biologics Evaluation and Research
This notice announces a forthcoming between approximately 12:30 p.m. to (CBER), the Center for Drug Evaluation
meeting of a public advisory committee 1:30 p.m. Time allotted for each and Research (CDER), and the Center for
of the Food and Drug Administration presentation may be limited. Those Devices and Radiological Health (CDRH)
(FDA). At least one portion of the desiring to make formal oral can receive regulatory submissions
meeting will be closed to the public. presentations should likewise notify the electronically. The FDA ESG enables
Name of Committee: Science contact person and submit a brief applicants to send applications and
jlentini on PROD1PC65 with NOTICES

Advisory Board (SAB) to the National statement of the general nature of the other submissions for review using the
Center for Toxicological Research evidence or arguments they wish to Internet, provides a single point of entry
(NCTR). present, the names and addresses of for these submissions, and fulfills goals
General Function of the Committee: proposed participants, and an identified in the Prescription Drug User
The Board advises the Director, NCTR, indication of the approximate time Fee Act (PDUFA III).

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