National Cancer Institute; Notice of Closed Meeting, 30469-30470 [05-10525]
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Federal Register / Vol. 70, No. 101 / Thursday, May 26, 2005 / Notices
• Timely and up-to-date; and
• Useful, that is, enables the
consumer to use the medicine properly
and appropriately, receive the
maximum benefit, and avoid harm.
The Action Plan includes descriptions
of the criteria.
1. The Pilot Study That Applied the
Action Plan Usefulness Criteria
To test a methodology for assessing
the usefulness of CMI in relation to the
requirements of the law, FDA contracted
with the National Association of Boards
of Pharmacy (NABP) to conduct a pilot
study. In 1998, NABP arranged for the
collection of written materials given to
patients who filled new prescriptions
for three commonly prescribed drugs
from a sample of State pharmacies. An
expert panel developed assessment
tools, applying the Action Plan criteria,
and used them to evaluate the
usefulness of the collected CMI
materials. The pilot study report4 was
presented by the director of the expert
panel and discussed by stakeholders at
an FDA public workshop from February
29 to March 1, 2000 (65 FR 7022,
February 11, 2000).
2. The National Study That Applied the
Action Plan Usefulness Criteria
In 2001, FDA commissioned NABP to
conduct a national study to assess the
extent to which the year 2000 goals
specified in the law had been achieved.
A random sample of pharmacies across
the continental United States was
selected. Patients submitted
prescriptions at each pharmacy for four
commonly prescribed drugs and
collected any written materials given to
them when the medications were
dispensed. The materials were sent to
an expert panel for evaluation against
the criteria endorsed by the Action Plan.
The results of the study were
announced in 2002.
On average, 89 percent of the patients
received some form of written
medication information. However, the
average usefulness of the information
was only about 50 percent. The
evaluation report5 is available on the
Internet at https://www.fda.gov/cder/
reports/prescriptioninfo/default.htm.
4 Svarstad, B. L. and D. C. Bultman, ‘‘Evaluation
of Written Prescription Information Provided in
Community Pharmacies: An 8-State Study,’’ interim
report to HHS and FDA, December 1999, available
on the Internet at https://www.fda.gov/cder/
calendar/meeting/rx2000/report1.htm.
5 Svarstad, B. L. and J. K. Mount, ‘‘Evaluation of
Written Prescription Information Provided in
Community Pharmacies, 2001,’’ final report to HHS
and FDA, December 2001.
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19:11 May 25, 2005
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3. The Advisory Committee Meeting
That Led to the Development of This
Guidance
The report findings were presented at
an FDA Drug Safety and Risk
Management Advisory Committee
(Advisory Committee) meeting on July
17, 2002 (67 FR 45982, July 11, 2002).
In addition, public comments were
requested about the steps the private
sector was taking to meet the target
goals of Public Law 104–180, possible
barriers to meeting the goals and plans
to overcome those barriers, the role FDA
should take in assuring full
implementation of the Action Plan, and
other initiatives FDA should consider in
facilitating achievement of the goals (68
FR 33724, June 5, 2003). The Advisory
Committee recommended that FDA take
a more active role in advising and
encouraging the private sector to meet
the next target goal set for 2006. A
transcript of FDA’s Drug Safety and Risk
Management Advisory Committee
meeting on July 17, 2002, is available on
the Internet at https://www.fda.gov/
ohrms/dockets/ac/02/transcripts/
3874t1.htm. Subsequent to the Advisory
Committee meeting, FDA stated its
belief that the voluntary approach to
improving the distribution of useful
CMI could still work to meet the
legislatively mandated 2006 level if
efforts to improve began immediately.
FDA considered the Advisory
Committee recommendations, the
public comments, and the findings of
strong CMI distribution rates but clear
deficiencies in quality, and identified
three specific areas in need of consensus
and action by the relevant stakeholders
to meet the 2006 goal. The following
areas were identified: (1)
Implementation (identifying roles and
responsibilities among the stakeholders
and methods for overcoming barriers to
meeting the goals); (2) evaluation
(determining how quality improvements
can be made in areas of CMI
deficiencies); and (3) education
(implementing procedures so that all
CMI developers, pharmacists, and
professional associations are aware of
the statutory requirements).
The agency met with various groups
and held a public meeting in 2003 (see
https://www.fda.gov/cder/offices/ods/
writtenprescripinfo.htm). In these
meetings, the agency was asked to
provide clarification on how the Action
Plan should be interpreted and
implemented. This guidance is a result
of that request. Specifically, this
guidance is intended to provide
recommendations to developers of CMI
regarding how best to evaluate current
CMI and develop future CMI to ensure
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30469
that all CMI meet the usefulness criteria
provided in the Action Plan. FDA
welcomes comments on all the topics
addressed by the guidance.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on useful written CMI. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the draft guidance. Submit
a single copy of electronic comments or
two paper copies of mailed comments,
except that individuals may submit one
paper copy. Comments are to be
identified with the docket number
found in brackets in the heading of this
document. The draft guidance and
received comments are available for
public examination in the Division of
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either http:/
/www.fda.gov/cder/guidance/index.htm
or https://www.fda.gov/ohrms/dockets/
default.htm.
Dated: May 18, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–10445 Filed 5–25–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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30470
Federal Register / Vol. 70, No. 101 / Thursday, May 26, 2005 / Notices
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel, NO1–CM–
57018–16.
Date: June 23–24, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Gaithersburg Hilton, 620 Perry
Parkway, Gaithersburg, MD 20877.
Contact Person: C. Michael Kerwin, PhD,
MPH, Scientific Review Administrator,
Special Review and Logistics Branch,
Division of Extramural Affairs, National
Cancer Institute, National Institutes of
Health, 6116 Executive Boulevard, Room
8057, MSC 8329, Bethesda, MD 20892–8329,
301–496–7421, kerwinm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: May 18, 2005.
LaVerne Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–10525 Filed 5–25–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute
Special Emphasis Panel, RFA: CA05–026.
Date: July 18–19, 2005.
Time: 8 a.m. to 5 p.m.
VerDate jul<14>2003
19:11 May 25, 2005
Jkt 205001
Agenda: To review and evaluate grant
applications and/or proposals.
Place: Holiday Inn Georgetown, 2101
Wisconsin Avenue, NW., Washington, DC
20007.
Contact Person: Sherwood Githens, PhD,
Scientific Review Administrator, Special
Review and Logistics Branch, National
Cancer Institute, Division of Extramural
Activities, 6116 Executive Blvd. Room 8053,
Bethesda, MD 20892, 301/435–1822,
githenss@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: May 18, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–10526 Filed 5–10–25; 8:45 am]
MD 20892–8329, 301–496–0694,
msalin@mail.nih.gov
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: May 18, 2005.
LaVerne Stringfield,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 05–10527 Filed 5–25–05; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting 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: National Cancer
Institute Special Emphasis Panel, Special
Emphasis Panel for K05s, K24s, and Two
types of R25 Applications.
Date: June 28–29, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Suites Alexandria, 480
King Street, Alexandria, VA 22314.
Contact Person: Marvin L. Salin, PHD,
Scientific Review Administrator, Special
Review and Logistics Branch, Division of
Extramural Activities, 6116 Executive
Boulevard, Room 7073, MSC8329, Bethesda,
PO 00000
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Fmt 4703
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
pubic 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: National Cancer
Institute Special Emphasis Panel, Innovative
Technologies for Molecular Analysis of
Cancer.
Date: June 16–17, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Double Tree Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Lalita D. Palekar, PhD,
Scientific Review Administrator, Special
Review and Resources Branch, Division of
Extramural Activities, National Cancer
Institute, National Institutes of Health, 6116
Executive Boulevard, Room 8105, Bethesda,
MD 20892–7405, (301) 496–7575.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
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[Federal Register Volume 70, Number 101 (Thursday, May 26, 2005)]
[Notices]
[Pages 30469-30470]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-10525]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the following
meeting.
The meeting 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning
[[Page 30470]]
individuals associated with the contract proposals, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy.
Name of Committee: National Cancer Institute Special Emphasis
Panel, NO1-CM-57018-16.
Date: June 23-24, 2005.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD
20877.
Contact Person: C. Michael Kerwin, PhD, MPH, Scientific Review
Administrator, Special Review and Logistics Branch, Division of
Extramural Affairs, National Cancer Institute, National Institutes
of Health, 6116 Executive Boulevard, Room 8057, MSC 8329, Bethesda,
MD 20892-8329, 301-496-7421, kerwinm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: May 18, 2005.
LaVerne Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-10525 Filed 5-25-05; 8:45 am]
BILLING CODE 4140-01-M
