Science Board to the Food and Drug Administration; Notice of Meeting, 16506 [05-6333]
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16506
Federal Register / Vol. 70, No. 61 / Thursday, March 31, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Cancellation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is canceling the
meeting of the Cardiovascular and Renal
Drugs Advisory Committee scheduled
for April 5, 2005. This meeting was
announced in the Federal Register of
March 9, 2005 (70 FR 11678).
FOR FURTHER INFORMATION CONTACT:
Cathy A. Groupe, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane, rm. 1093), Rockville, MD
20857, 301–827–7001, e-mail:
Groupc@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area) code 3014512533.
Dated: March 24, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–6331 Filed 3–25–05; 3:50 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Science Board to the Food and Drug
Administration; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Science Board to
the Food and Drug Administration.
General Function of the Committee:
The Board shall provide advice
primarily to the agency’s Senior Science
Advisor and, as needed, to the
Commissioner and other appropriate
officials on specific complex and
technical issues as well as emerging
issues within the scientific community
in industry and academia. Additionally,
the Board will provide advice to the
agency on keeping pace with technical
and scientific evolutions in the fields of
regulatory science, on formulating an
appropriate research agenda, and on
VerDate jul<14>2003
15:30 Mar 30, 2005
Jkt 205001
upgrading its scientific and research
facilities to keep pace with these
changes. It will also provide the means
for critical review of agency-sponsored
intramural and extramural scientific
research programs
Date and Time: The meeting will be
held on April 15, 2005, 8:30 a.m. to 5
p.m.
Location: Food and Drug
Administration, 5630 Fishers Lane, rm.
1066, Rockville, MD 20857.
Contact Person: Jan Johannessen,
Office of the Commissioner (HF–33),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–6687, e-mail:
jjohannessen@fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512603. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: The Board will hear about
and discuss the following topics: (1) The
agency’s pre- and postmarketing safety
programs for drugs and biologics and (2)
Good Manufacturing Practices for
vaccines, blood, and cell, tissue, and
gene products.
Procedure: 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 by April 8, 2005. Oral
presentations from the public will be
scheduled between approximately 1:30
p.m. and 2:30 p.m. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before April 8, 2005, 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
requested to make their presentation.
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 Jan
Johannessen 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).
PO 00000
Frm 00031
Fmt 4703
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Dated: March 24, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–6333 Filed 3–25–05; 3:51 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Summaries of Medical and Clinical
Pharmacology Reviews of Pediatric
Studies; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of summaries of medical
and clinical pharmacology reviews of
pediatric studies submitted in
supplements for AGRYLIN (anagrelide),
CLOLAR (clofarabine), and DIFLUCAN
(fluconazole). These summaries are
being made available consistent with
the Best Pharmaceuticals for Children
Act (BPCA). For all pediatric
supplements submitted under the
BPCA, the BPCA requires FDA to make
available to the public a summary of the
medical and clinical pharmacology
reviews of the pediatric studies
conducted for the supplement.
ADDRESSES: Submit written requests for
single copies of the summaries to the
Division of Drug Information (HFD–
240), Center for Drug Evaluation and
Research, Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857. Please specify by
product name which summary or
summaries you are requesting. Send one
self-addressed adhesive label to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
summaries.
FOR FURTHER INFORMATION CONTACT:
Grace Carmouze, Center for Drug
Evaluation and Research (HFD–960),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–594–7337, e-mail:
carmouzeg@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
summaries of medical and clinical
pharmacology reviews of pediatric
studies conducted for AGRYLIN
(anagrelide), CLOLAR (clofarabine), and
DIFLUCAN (fluconazole). The
summaries are being made available
E:\FR\FM\31MRN1.SGM
31MRN1
]]>Agencies
[Federal Register Volume 70, Number 61 (Thursday, March 31, 2005)]
[Notices]
[Page 16506]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-6333]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Science Board to the Food and Drug Administration; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Science Board to the Food and Drug
Administration.
General Function of the Committee: The Board shall provide advice
primarily to the agency's Senior Science Advisor and, as needed, to the
Commissioner and other appropriate officials on specific complex and
technical issues as well as emerging issues within the scientific
community in industry and academia. Additionally, the Board will
provide advice to the agency on keeping pace with technical and
scientific evolutions in the fields of regulatory science, on
formulating an appropriate research agenda, and on upgrading its
scientific and research facilities to keep pace with these changes. It
will also provide the means for critical review of agency-sponsored
intramural and extramural scientific research programs
Date and Time: The meeting will be held on April 15, 2005, 8:30
a.m. to 5 p.m.
Location: Food and Drug Administration, 5630 Fishers Lane, rm.
1066, Rockville, MD 20857.
Contact Person: Jan Johannessen, Office of the Commissioner (HF-
33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-6687, e-mail: jjohannessen@fda.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 3014512603. Please call the Information Line
for up-to-date information on this meeting.
Agenda: The Board will hear about and discuss the following topics:
(1) The agency's pre- and postmarketing safety programs for drugs and
biologics and (2) Good Manufacturing Practices for vaccines, blood, and
cell, tissue, and gene products.
Procedure: 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 by April 8, 2005.
Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before April 8, 2005,
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 requested to
make their presentation.
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 Jan Johannessen 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: March 24, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-6333 Filed 3-25-05; 3:51 pm]
BILLING CODE 4160-01-S
