Oncologic Drugs Advisory Committee; Amendment of Notice, 62126 [05-21493]
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62126
Federal Register / Vol. 70, No. 208 / Friday, October 28, 2005 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee;
Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of the meeting of the
Oncologic Drugs Advisory Committee.
This meeting was announced in the
Federal Register of October 14, 2005 (70
FR 60094). The amendment is being
made to reflect changes in the Agenda
portion of the document. There are no
other changes.
FOR FURTHER INFORMATION CONTACT:
Johanna Clifford, Center for Drug
Evaluation and Research (HFD–21),
Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630
Fishers Lane, rm. 1093), Rockville, MD
20857, 301–827–7001, FAX: 301–827–
6776 or email: cliffordj@cder.fda.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of October 14, 2005,
FDA announced that a meeting of the
Oncologic Drugs Advisory Committee
will be held on November 8, 2005. On
page 60094, beginning in the third
column, and continuing on page 60095,
the Agenda portion of the meeting is
amended to read as follows:
Agenda: The committee will discuss
new drug applications approved under
21 CFR 314.500 and 601.40 (subparts H
and subpart E, respectively, accelerated
approval regulations) in an open session
to do the following: (1) Review the
status of phase IV clinical studies; (2)
identify difficulties associated with
completion of phase IV commitments;
and (3) provide advice to sponsors to
assist in the planning and execution of
postmarketing commitments of newly
approved drugs. The committee will
discuss phase IV commitments of: (1)
New drug application (NDA) 50–718,
DOXIL (doxorubicin hydrochloride
liposome injection, Johnson and
Johnson Pharmaceutical Research and
Development, L.L.C.) for the treatment
of acquired immune deficiency
syndrome (AIDS) related Kaposi’s
sarcoma in patients with disease that
has progressed on prior combination
therapy or in patients who are intolerant
to such therapy; (2) biologics license
application (BLA) 103767/0, ONTAK
(denileukin diftitox, Seragen
Incorporated) for the treatment of
patients with persistent or recurrent
cutaneous T-cell lymphoma whose
VerDate Aug<31>2005
18:15 Oct 27, 2005
Jkt 208001
malignant cells express the CD25
component of the interleukin-2 receptor;
(3) NDA 21–041, DEPOCYT (cytarabine
liposome injection, SkyePharma Inc.)
for the intrathecal treatment of
lymphomatous meningitis; (4) NDA 21–
156, CELEBREX (celecoxib capsules,
Pfizer Inc.) for reducing the number of
adenomatous colorectal polyps in
familial adenomatous polyposis (FAP),
as an adjunct to usual care (e.g.,
endoscopic surveillance, surgery); (5)
NDA 21–174, MYLOTARG
(gemtuzumab ozogamicin for injection,
Wyeth Pharmaceuticals, Inc.) for the
treatment of patients with CD33 positive
acute myeloid leukemia in first relapse
who are 60 years of age or older and
who are not considered candidates for
other cytotoxic chemotherapy; and (6)
BLA 103948/0, CAMPATH
(alemtuzumab, ILEX Pharmaceuticals,
L.P.) for the treatment of B-cell chronic
lymphocytic leukemia (B–CLL) in
patients who have been treated with
alkylating agents and who have failed
fludarabine therapy.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: October 21, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–21493 Filed 10–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0410]
Prescription Drug User Fee Act; Public
Meeting; Correction
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
correction.
ACTION:
SUMMARY: The Food and Drug
Administration is correcting a notice
that appeared in the Federal Register of
October 18, 2005 (70 FR 60536). The
document announced a public meeting
on the Prescription Drug User Fee Act
(PDUFA). The document was published
with typographical errors in the DATES
and FOR FURTHER INFORMATION CONTACT
sections of the document. This
document corrects those errors.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy (HF–27),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–7010.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
In FR Doc.
05–20875, appearing on page 60536 in
the Federal Register of Tuesday,
October 18, 2005, the following
corrections are made:
1. On page 60536, in the second
column, the third sentence under DATES
is corrected to read: ‘‘You may register
electronically at
CBERTrainingSuggestions
@cber.fda.gov.’’
2. On page 60536, in the second
column, in the FOR FURTHER
INFORMATION CONTACT section, beginning
in the fifth line, the telephone number
‘‘301–827–2647’’ is corrected to read
‘‘301–827–5902’’.
SUPPLEMENTARY INFORMATION:
Dated: October 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–21525 Filed 10–27–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic Drugs Advisory
Committee; 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:
Psychopharmacologic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 2, 2005, from 8 a.m.
to 5 p.m.
Location: Hilton, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD, 301–
977–8900.
Contact Person: Cicely Reese, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–7001, FAX: 301–
827–6776, e-mail:
ReeseCi@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. Please call the Information
Line for up-to-date information on this
meeting. The background material will
E:\FR\FM\28OCN1.SGM
28OCN1
]]>Agencies
[Federal Register Volume 70, Number 208 (Friday, October 28, 2005)]
[Notices]
[Page 62126]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21493]
[[Page 62126]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of the meeting of the Oncologic Drugs Advisory Committee.
This meeting was announced in the Federal Register of October 14, 2005
(70 FR 60094). The amendment is being made to reflect changes in the
Agenda portion of the document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: Johanna Clifford, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093),
Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776 or email:
cliffordj@cder.fda.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 14, 2005,
FDA announced that a meeting of the Oncologic Drugs Advisory Committee
will be held on November 8, 2005. On page 60094, beginning in the third
column, and continuing on page 60095, the Agenda portion of the meeting
is amended to read as follows:
Agenda: The committee will discuss new drug applications approved
under 21 CFR 314.500 and 601.40 (subparts H and subpart E,
respectively, accelerated approval regulations) in an open session to
do the following: (1) Review the status of phase IV clinical studies;
(2) identify difficulties associated with completion of phase IV
commitments; and (3) provide advice to sponsors to assist in the
planning and execution of postmarketing commitments of newly approved
drugs. The committee will discuss phase IV commitments of: (1) New drug
application (NDA) 50-718, DOXIL (doxorubicin hydrochloride liposome
injection, Johnson and Johnson Pharmaceutical Research and Development,
L.L.C.) for the treatment of acquired immune deficiency syndrome (AIDS)
related Kaposi's sarcoma in patients with disease that has progressed
on prior combination therapy or in patients who are intolerant to such
therapy; (2) biologics license application (BLA) 103767/0, ONTAK
(denileukin diftitox, Seragen Incorporated) for the treatment of
patients with persistent or recurrent cutaneous T-cell lymphoma whose
malignant cells express the CD25 component of the interleukin-2
receptor; (3) NDA 21-041, DEPOCYT (cytarabine liposome injection,
SkyePharma Inc.) for the intrathecal treatment of lymphomatous
meningitis; (4) NDA 21-156, CELEBREX (celecoxib capsules, Pfizer Inc.)
for reducing the number of adenomatous colorectal polyps in familial
adenomatous polyposis (FAP), as an adjunct to usual care (e.g.,
endoscopic surveillance, surgery); (5) NDA 21-174, MYLOTARG (gemtuzumab
ozogamicin for injection, Wyeth Pharmaceuticals, Inc.) for the
treatment of patients with CD33 positive acute myeloid leukemia in
first relapse who are 60 years of age or older and who are not
considered candidates for other cytotoxic chemotherapy; and (6) BLA
103948/0, CAMPATH (alemtuzumab, ILEX Pharmaceuticals, L.P.) for the
treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients
who have been treated with alkylating agents and who have failed
fludarabine therapy.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: October 21, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-21493 Filed 10-27-05; 8:45 am]
BILLING CODE 4160-01-S
