Center for Scientific Review; Notice of Closed Meetings, 57320 [E9-26689]
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Federal Register / Vol. 74, No. 213 / Thursday, November 5, 2009 / Notices
and over-the-counter (OTC) medications
to stay healthy. Yet it is widely known
that too many people incur preventable
injury and even die from medication
errors or misuse. Preventable injuries
can result from a variety of sources,
including informational errors (mistakes
made in prescribing or using a medicine
because of inadequate information);
unintended, or accidental exposure;
intentional drug misuse and abuse; and
rarely because of manufacturing and/or
distribution defects. The Institute of
Medicine (IOM) estimates that 1.5
million preventable injuries, or adverse
drug events, occur in the United States
healthcare system each year,1,2 at a cost
exceeding $4 billion annually.
Additionally, incorrect use of OTC
medications results in thousands of
preventable injuries. Furthermore,
unintended exposure to medications
causes a significant number of injuries
and deaths, mainly in children. Between
2003 and 2006 alone, more than 9,000
children were accidentally exposed to
prescription opioid drugs.3
These potentially avoidable injuries
and deaths represent our society’s
collective failure to adequately manage
medication risks. Because the
shortcomings in the healthcare system
have been broadly acknowledged, FDA
and many other healthcare stakeholders
have been working hard to improve the
way in which the nation’s healthcare
system manages medication risks.
However, much more needs to be done,
and coordinated cross-sector efforts,
involving all stakeholders, would have
the greatest impact.
To this end, FDA is launching the
Safe Use Initiative, through which it
will collaborate with stakeholders—
including patients, consumers,
caretakers, healthcare practitioners,
pharmacists, healthcare systems, health
insurers, drug manufacturers, and
Federal agencies—to identify specific
candidate cases associated with
important, measurable amounts of
preventable harm. In the coming
months, FDA plans to develop, through
extensive consultation with all
interested public and private
stakeholders, a general list of candidate
cases for collaborative analysis and
erowe on DSK5CLS3C1PROD with NOTICES
1 Institute
of Medicine of the National Academies,
Preventing Medication Errors, National Academies
Press, p. 124, 2007.
2 Ibid, p. 4. The IOM defines an adverse drug
event (ADE) as any injury due to medication.
Examples include a wrong dosage leading to injury
(e.g., rash, confusion, or loss of function) or an
allergic reaction occurring in a patient not known
to be allergic to a given medication.
3 Bailey, J.E., E. Campagna, R.C. Dart, ‘‘The
Underrecognized Toll of Prescription Opioid Abuse
on Young Children,’’ Annals of Emergency
Medicine, 53:4129–24, 2009.
VerDate Nov<24>2008
14:57 Nov 04, 2009
Jkt 220001
intervention. FDA also intends to work
with federal partners to develop
population-based national estimates of
preventable harm from medications,
categorized by drug, drug classes, and
therapeutic situations. In addition to
opening a docket to receive public
input, FDA plans to hold a series of
public meetings to gather broad public
feedback as the candidate list is being
developed. It is FDA’s goal to
implement a small number of
interventions during the next 12
months.
For more information, see FDA’s Safe
Use Web page at https://www.fda.gov/
Drugs/DrugSafety/ucm187806.htm.
II. Submission of Feedback on the
Contents of This Docket
Interested parties may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments on this information. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments. Individuals may submit one
paper copy. Comments should be
identified with the docket number
found in brackets in this document’s
heading. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday. FDA will
accept electronic comments or
submissions only at https://www.
regulations.gov.
Dated: October 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–26530 Filed 11–4–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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.
PO 00000
Frm 00036
Fmt 4703
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts in Motor Function.
Date: November 13, 2009.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
(Telephone Conference Call)
Contact Person: Dana Jeffrey Plude, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, 301–435–
2309, pluded@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Review of
BSCH Member Conflict Applications
Date: November 17, 2009.
Time: 2:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Ritz Carlton Hotel, 1150 22nd Street,
NW., Washington, DC 20037.
Contact Person: Jose H. Guerrier, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1137, guerriej@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Genes, Genomes, and Genetics.
Date: November 19, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Avenue, NW., Washington, DC 20037.
Contact Person: Michael A. Marino, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2216,
MSC 7890, Bethesda, MD 20892, (301) 435–
0601, marinomi@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 30, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–26689 Filed 11–4–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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[Federal Register Volume 74, Number 213 (Thursday, November 5, 2009)]
[Notices]
[Page 57320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26689]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meetings.
The meetings 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: Center for Scientific Review Special Emphasis
Panel; Member Conflicts in Motor Function.
Date: November 13, 2009.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892. (Telephone Conference Call)
Contact Person: Dana Jeffrey Plude, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176, MSC 7848, Bethesda, MD
20892, 301-435-2309, pluded@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Review of BSCH Member Conflict Applications
Date: November 17, 2009.
Time: 2:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Ritz Carlton Hotel, 1150 22nd Street, NW., Washington, DC
20037.
Contact Person: Jose H. Guerrier, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD
20892, 301-435-1137, guerriej@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Genes, Genomes, and Genetics.
Date: November 19, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Melrose Hotel, 2430 Pennsylvania Avenue, NW., Washington,
DC 20037.
Contact Person: Michael A. Marino, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2216, MSC 7890, Bethesda, MD
20892, (301) 435-0601, marinomi@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: October 30, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-26689 Filed 11-4-09; 8:45 am]
BILLING CODE 4140-01-P
