Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting, 942-943 [E5-8332]

Download as PDF 942 Federal Register / Vol. 71, No. 4 / Friday, January 6, 2006 / Notices FDA is issuing this guidance as a level 1 guidance consistent with FDA’s good guidance practices regulation § 10.115 (21 CFR 10.115). Consistent with FDA’s good guidance practices regulation, the agency will accept comment, but is implementing the guidance document immediately in accordance with § 10.115 (g)(2), because the agency has determined that prior public participation is not feasible or appropriate. This document affects the trans fat labeling effective date of January 1, 2006, so it is urgent that FDA explains its new enforcement policy before that date. This guidance represents the agency’s current thinking on the subject. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT). II. Paperwork Reduction Act of 1995 This final guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collection of information in this guidance was approved under OMB control number 0910–0571. III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document at any time. Submit a single copy of electronic comments or two paper copies of any 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 guidance and received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. cprice-sewell on PROD1PC66 with NOTICES IV. Electronic Access Persons with access to the Internet may obtain the guidance document at https://www.cfsan.fda.gov/ guidance.html. Dated: January 3, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–116 Filed 1–3–06; 3:14 pm] BILLING CODE 4160–01–S VerDate Aug<31>2005 15:23 Jan 05, 2006 Jkt 208001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management 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: Drug Safety and Risk Management 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 February 9, 2006, from 8 a.m. to 5 p.m. and February 10, 2006, from 8 a.m. to 3 p.m. Location: Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: Victoria FerrettiAceto, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–7001, FAX: 301–827–6776, e-mail: ferrettiv@cder.fda.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512535. Please call the Information Line for up-to-date information on this meeting. Agenda: Cases of sudden death and serious adverse events including hypertension, myocardial infarction, and stroke have been reported to the agency in association with therapeutic doses of drugs used to treat Attention Deficit Hyperactivity Disorder (ADHD) in both pediatric and adult populations. The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks. On February 9, 2006, the committee will be asked to discuss approaches that could be used to study whether these products increase the risk of adverse cardiovascular outcomes. On February 10, 2006, the committee will be briefed on developments in the Office of Drug Safety and will receive updates on the Drug Safety Oversight Board and agency actions for the COX–2 selective Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and the risk management program for the isotretinoin products. Background materials for this meeting will be posted 1 business day before the PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 meeting on FDA’s Web site at https:// www.fda.gov/ohrms/dockets/ac/ acmenu.htm (click on the year 2006 and scroll down to Drug Safety and Risk Management Advisory Committee). 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 2, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on February 9, 2006, and between approximately 8:15 a.m. and 9:15 a.m. on February 10, 2006. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 2, 2006, 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 Victoria Ferretti-Aceto 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: December 27, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E6–6 Filed 1–5–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Pediatric Oncology Subcommittee of the 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. E:\FR\FM\06JAN1.SGM 06JAN1 cprice-sewell on PROD1PC66 with NOTICES Federal Register / Vol. 71, No. 4 / Friday, January 6, 2006 / Notices Name of Committee: Pediatric Oncology Subcommittee of the 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 March 14, 2006, from 8 a.m. to 5 p.m. Location: Gaithersburg 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: The subcommittee will discuss the following: (1) Clinical studies of methotrexate and daunomycin to be conducted under the Best Pharmaceuticals for Children Act; (2) phase 4 requirements for Deferasirox, Norvartis Pharmaceuticals, as mandated under accelerated approval; and (3) the Center for Drug Evaluation and Research’s process for handling drug shortages. The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site at https:// www.fda.gov/ohrms/dockets/ac/ acmenu.htm under the heading ‘‘Oncologic Drugs Advisory Committee; Pediatric Oncology’’ (click on the year 2006 and scroll down to the previously named committee). Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittee. Written submissions may be made to the contact person by March 7, 2006. Oral presentations from the public will be scheduled between approximately 2 p.m. to 3 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 7, 2006, 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 VerDate Aug<31>2005 15:23 Jan 05, 2006 Jkt 208001 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 Johanna M. Clifford 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: December 27, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E5–8332 Filed 1–5–06; 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. 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 March 15, 2006, from 8 a.m. to 5 p.m. Location: Gaithersburg 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, 301–8277001, 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. The background material will become available no later than the day before the meeting and will be posted on FDA’s Web site at https:// www.fda.gov/ohrms/dockets/ac/ PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 943 acmenu.htm under the heading ‘‘Oncologic Drugs Advisory Committee’’ (click on the year 2006 and scroll down to the above named committee meeting). Agenda: The committee will discuss the following: (1) Receive and discuss pediatric update from the October 20, 2005, meeting of the Pediatric Oncology Subcommittee; (2) discuss pre-clinical requirements and phase 1 trial design issues for the development of oncologic products; and (3) discuss new drug application (NDA) 20–509, S–039, GEMZAR (gemcitabine hydrochloride) for Injection, Eli Lilly & Co., proposed indication for use in combination with carboplatin for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. 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 March 7, 2006. 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. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 7, 2006, 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 Johanna Clifford 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: December 27, 2005. Jason Brodsky, Acting Associate Commissioner for External Relations. [FR Doc. E5–8333 Filed 1–5–06; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\06JAN1.SGM 06JAN1

Agencies

[Federal Register Volume 71, Number 4 (Friday, January 6, 2006)]
[Notices]
[Pages 942-943]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E5-8332]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pediatric Oncology Subcommittee of the 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.

[[Page 943]]

    Name of Committee: Pediatric Oncology Subcommittee of the 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 March 14, 2006, from 8 a.m. 
to 5 p.m.
    Location: Gaithersburg 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: The subcommittee will discuss the following: (1) Clinical 
studies of methotrexate and daunomycin to be conducted under the Best 
Pharmaceuticals for Children Act; (2) phase 4 requirements for 
Deferasirox, Norvartis Pharmaceuticals, as mandated under accelerated 
approval; and (3) the Center for Drug Evaluation and Research's process 
for handling drug shortages. The background material will become 
available no later than the day before the meeting and will be posted 
on FDA's Web site at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm 
under the heading ``Oncologic Drugs Advisory Committee; Pediatric 
Oncology'' (click on the year 2006 and scroll down to the previously 
named committee).
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
Written submissions may be made to the contact person by March 7, 2006. 
Oral presentations from the public will be scheduled between 
approximately 2 p.m. to 3 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before March 7, 2006, 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 Johanna M. Clifford 
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: December 27, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E5-8332 Filed 1-5-06; 8:45 am]
BILLING CODE 4160-01-S

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