Oncologic Drugs Advisory Committee; Notice of Meeting, 6016 [05-2208]

Download as PDF 6016 Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Notices FOR FURTHER INFORMATION CONTACT: Regarding the administrative and financial management aspects of this notice: Michelle N. Caraffa (see ADDRESSES). Regarding the programmatic aspects of this notice: Stephen Toigo, Division of Federal-State Relations (DFSR), Office of Regulatory Affairs, Food and Drug Administration (HFC–150), 5600 Fishers Lane, rm. 12–07, Rockville, MD 20857, 301– 827–6906, or access the Internet at: https://www.fda.gov/ora/fed_state/ default.htm. For general ORA program information contact your Regional Food Specialists at https:// www.fda.gov/ora/fed_state/ DFSR_Activities/ food_specialists.htm On page 35653 in the first column, under section V.A, a sentence is added at the end of the paragraph that reads: ‘‘A Current Listing of SPOCs can be found at https://www.whitehouse.gov/ omb/grants/spoc.html.’’ On page 35653 in the third column, under section VII, the paragraph is revised to read: ‘‘Applicants are encouraged to apply electronically (see ADDRESSES). If not, the original and two copies of the completed grant application Form PHS–5161–1 (Revised 7/00) for State and local governments should be delivered to the Grants Management Office. The receipt date is March 15, 2005. No supplemental material or addenda will be accepted after the receipt date.’’ On page 35653 in the third column, under section VIII.A in the second paragraph, the last sentence should read: ‘‘FDA is now accepting applications via the Internet.’’ Dated: January 31, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–2209 Filed 2–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Oncologic 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. VerDate jul<14>2003 18:52 Feb 03, 2005 Jkt 205001 Name of Committee: Oncologic 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 March 3, 2005, from 8 a.m. to 5 p.m. and March 4, 2005, from 8 a.m. to 1 p.m. Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Johanna M. 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, e-mail: cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512542. Please call the Information Line for up-to-date information on this meeting. Agenda: On March 3, 2005, the committee will do the following: (1) Discuss new drug application (NDA) 21–115, COMBIDEX (ferumoxtran–10), Advanced Magnetics, Inc., proposed indication for intravenous administration as a magnetic resonance imaging contrast agent to assist in the differentiation of metastatic and nonmetastatic lymph nodes in patients with confirmed primary cancer who are at risk for lymph node metastases, and (2) discuss prostate cancer endpoints as a followup to the June 2004 FDA workshop. On March 4, 2005, the committee will do the following: (1) Discuss the results of a confirmatory trial for NDA 21–399, IRESSA (gefitinib) AstraZeneca Pharmaceticals LP, for the treatment of patients with locally advanced or metastatic nonsmall cell lung cancer after failure of both platinum-based and docetaxel chemotherapies, and (2) discuss safety concerns, specifically osteonecrosis of the jaw (ONJ), associated with two bisphosphonates, NDA 21–223, ZOMETA (zoledronic acid) Injection and AREDIA (pamidronate disodium for injection), both from Novartis Pharmaceuticals Corp. ZOMETA is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. It is also approved for hypercalcemia of malignancy. AREDIA is indicated, in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 metastases of breast cancer and osteolytic lesions of multiple myeloma. It is also indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, and treatment of patients with moderate to severe Paget’s disease of bone. 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 February 28, 2005. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on March 3, 2005, and between approximately 10:30 a.m. to 11 a.m. on March 4, 2005. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 28, 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 Trevelin Prysock at 301–827–7001, 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: January 27, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–2208 Filed 2–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Development of Revised Need for Assistance Criteria for Assessing Community Need for Comprehensive Primary and Preventive Health Care Services Under the President’s Health Centers Initiative Health Resources and Services Administration, HHS. AGENCY: E:\FR\FM\04FEN1.SGM 04FEN1

Agencies

[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Notices]
[Page 6016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2208]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Oncologic 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 March 3, 2005, from 8 
a.m. to 5 p.m. and March 4, 2005, from 8 a.m. to 1 p.m.
    Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Johanna M. 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, e-mail: cliffordj@cder.fda.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512542. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: On March 3, 2005, the committee will do the following: (1) 
Discuss new drug application (NDA) 21-115, COMBIDEX (ferumoxtran-10), 
Advanced Magnetics, Inc., proposed indication for intravenous 
administration as a magnetic resonance imaging contrast agent to assist 
in the differentiation of metastatic and nonmetastatic lymph nodes in 
patients with confirmed primary cancer who are at risk for lymph node 
metastases, and (2) discuss prostate cancer endpoints as a followup to 
the June 2004 FDA workshop. On March 4, 2005, the committee will do the 
following: (1) Discuss the results of a confirmatory trial for NDA 21-
399, IRESSA (gefitinib) AstraZeneca Pharmaceticals LP, for the 
treatment of patients with locally advanced or metastatic nonsmall cell 
lung cancer after failure of both platinum-based and docetaxel 
chemotherapies, and (2) discuss safety concerns, specifically 
osteonecrosis of the jaw (ONJ), associated with two bisphosphonates, 
NDA 21-223, ZOMETA (zoledronic acid) Injection and AREDIA (pamidronate 
disodium for injection), both from Novartis Pharmaceuticals Corp. 
ZOMETA is indicated for the treatment of patients with multiple myeloma 
and patients with documented bone metastases from solid tumors, in 
conjunction with standard antineoplastic therapy. Prostate cancer 
should have progressed after treatment with at least one hormonal 
therapy. It is also approved for hypercalcemia of malignancy. AREDIA is 
indicated, in conjunction with standard antineoplastic therapy, for the 
treatment of osteolytic bone metastases of breast cancer and osteolytic 
lesions of multiple myeloma. It is also indicated for the treatment of 
moderate or severe hypercalcemia associated with malignancy, and 
treatment of patients with moderate to severe Paget's disease of bone.
    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 February 28, 
2005. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on March 
3, 2005, and between approximately 10:30 a.m. to 11 a.m. on March 4, 
2005. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before February 28, 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 Trevelin Prysock at 
301-827-7001, 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: January 27, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-2208 Filed 2-3-05; 8:45 am]
BILLING CODE 4160-01-S

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