Notices. Notice
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BILLING CODE 4160-01-S 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 Ferretti-Aceto, 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 meeting on FDA's Web site at *http://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. *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 *http://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 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, 301-827-7001, 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. The background material will become available no later than the day before the meeting and will be posted on FDA's Web site at *http://www.fda.gov/ohrms/dockets/ac/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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225-05-8007] Implementation Plan for the Memorandum of Understanding Regarding the Sharing and Exchange of Information About Therapeutic Products Between the Food and Drug Administration Department of Health and Human Services of the United States of America and Health Products and Food Branch, Health Canada of Canada AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is providing notice of an Implementation Plan (Implementation Plan) for the Memorandum of Understanding
(MOU)Regarding the Sharing and Exchange of Information About Therapeutic Products Between the Food and Drug Administration Department of Health and Human Services of the United States of America and the Health Products and Food Branch, Health Canada of Canada. The purpose of the Implementation Plan is to establish the following: A governance structure for directing and monitoring the implementation of the MOU; clear process by which each party will undertake the exchange of otherwise not public information; and the process for setting and monitoring mutually agreed upon annual priorities for cooperation. DATES: The Implementation Plan became effective December 1, 2005. FOR FURTHER INFORMATION CONTACT: Matthew E. Eckel, Office of International Programs, (HFG-1), 5600 Fishers Lane, Rockville MD, 20857, 301-827-4480, FAX: 301-480-0716. SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(a) and (c), which states that all written agreements and understandings signed by FDA and other departments, agencies, and organizations shall be published in the **Federal Register** , except those agreements and memoranda of understanding between FDA and State or local government agencies that are cooperative work-sharing agreements, the agency is publishing notice of this Implementation Plan. Dated: December 30, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160-01-S EN06JA06.366 EN06JA06.367 EN06JA06.368 EN06JA06.369 EN06JA06.370 EN06JA06.371 [FR Doc. 06-113 Filed 1-5-06; 8:45 am]