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Notice: Human drugs:
Patent extension; regulatory review period determinations—
Pediatric Advisory Committee, 67179 [05-22014] Food and Drug Administration
Titlu original
Notice: Human drugs:
Patent extension; regulatory review period determinations— Pediatric Advisory Committee
Notice: Human drugs:
Patent extension; regulatory review period determinations—
Pediatric Advisory Committee, 67179 [05-22014] Food and Drug Administration
Drepturi de autor:
Public Domain
Formate disponibile
Descărcați ca PDF, TXT sau citiți online pe Scribd
Notice: Human drugs:
Patent extension; regulatory review period determinations—
Pediatric Advisory Committee, 67179 [05-22014] Food and Drug Administration
Drepturi de autor:
Public Domain
Formate disponibile
Descărcați ca PDF, TXT sau citiți online pe Scribd
SUPPLEMENTARY INFORMATION: In FR Doc. 1–800–741–8138 (301–443–0572 in the DEPARTMENT OF HEALTH AND
03–4691, appearing on page 9690 in the Washington, DC area), code HUMAN SERVICES Federal Register of February 28, 2003, 8732310001. Please call the Information the following corrections are made: Line for up-to-date information on this Food and Drug Administration 1. On page 9690, in the third column, meeting. in the first complete paragraph, in the Agenda: The committee will discuss a Advisory Committee on Special third line, ‘‘2,810’’ is corrected to read report by the agency on Adverse Event Studies Relating to the Possible Long- ‘‘2,901’’; in the fourth line, ‘‘2,201’’ is Reporting, as mandated in Section 17 of Term Health Effects of Phenoxy corrected to read ‘‘2,292’’. the Best Pharmaceuticals for Children Herbicides and Contaminants (Ranch 2. On page 9690, in the third column, Act, for AGRYLIN (anagrelide), Hand Advisory Committee); Notice of in the second complete paragraph, PARAPLATIN (carboplatin), DIFLUCAN Meeting beginning in the fourth line, ‘‘December (fluconazole), CAMPTOSAR AGENCY: Food and Drug Administration, 12, 1993’’ is corrected to read (irinotecan), TAMIFLU (oseltamivir), HHS. ‘‘September 12, 1993’’; in line 10, VIOXX (rofecoxib), FERRLECIT (sodium ‘‘December 12, 1993’’ is corrected to ACTION: Notice. ferric gluconate complex), and IMITREX read ‘‘September 12, 1993’’. (sumatriptan). This notice announces a forthcoming Dated: October 20, 2005. The background material will become meeting of a public advisory committee Jane A. Axelrad, available no later than the day before of the Food and Drug Administration the meeting and will be posted under (FDA). The meeting will be open to the Associate Director for Policy, Center for Drug Evaluation and Research. the Pediatric Advisory Committee public. Docket site at http://www.fda.gov/ Name of Committee: Advisory [FR Doc. 05–22012 Filed 11–3–05; 8:45 am] ohrms/dockets/ac/acmenu.htm. (Click Committee on Special Studies Relating BILLING CODE 4160–01–S on the year 2005 and scroll down to to the Possible Long-Term Health Effects Pediatric Advisory Committee of Phenoxy Herbicides and meetings.) Contaminants (Ranch Hand Advisory DEPARTMENT OF HEALTH AND HUMAN SERVICES Committee). Procedure: Interested persons may Food and Drug Administration present data, information, or views, General Function of the Committee: orally or in writing, on issues pending To advise the Secretary of Health and Pediatric Advisory Committee; Notice before the committee. Written Human Services (the Secretary) and the of Meeting submissions may be made to the contact Assistant Secretary for Health person by November 10, 2005. Oral concerning its oversight of the conduct AGENCY: Food and Drug Administration, presentations from the public will be HHS. of the Ranch Hand study by the U.S. Air scheduled on Friday, November 18, Force and provide scientific oversight of ACTION: Notice. 2005, between approximately 8:30 a.m. the Department of Veterans Affairs and 9:30 a.m. Time allotted for each Army Chemical Corps Vietnam Veterans This notice announces a forthcoming presentation may be limited. Those meeting of a public advisory committee Health Study, and other studies in desiring to make formal oral which the Secretary or the Assistant of the Food and Drug Administration presentations should notify the contact (FDA). The meeting will be open to the Secretary for Health believes person by November 10, 2005, and involvement by the committee is public. submit a brief statement of the general Name of Committee: Pediatric desirable. nature of the evidence or arguments Advisory Committee. they wish to present, the names and General Function of the Committee: Date and Time: The meeting will be addresses of proposed participants, and held on November 18, 2005, from 8:30 To provide advice and an indication of the approximate time a.m. to 4 p.m. recommendations to the agency on requested to make their presentation. Location: Food and Drug FDA’s regulatory issues. The committee Persons attending FDA’s advisory also advises and makes Administration, 5630 Fishers Lane, rm. committee meetings are advised that the recommendations to the Secretary under 1066, Rockville, MD 20857. agency is not responsible for providing 45 CFR 46.407 on research involving Contact Person: Leonard Schechtman, access to electrical outlets. children as subjects that is conducted or FDA welcomes the attendance of the National Center for Toxicological supported by the Department of Health public at its advisory committee Research (HFT–10), Food and Drug and Human Services, when that meetings and will make every effort to Administration, 5600 Fishers Lane, research is also regulated by FDA. accommodate persons with physical Rockville, MD 20857, 301–827–6696, or Date and Time: The meeting will be disabilities or special needs. If you FDA Advisory Committee Information held on Friday, November 18, 2005, require special accommodations due to Line, 1–800–741–8138 (301–443–0572 from 8 a.m. to 2 p.m. a disability, please contact Jan in the Washington, DC area), code Location: Washington DC North/ Johannessen at least 7 days in advance 3014512560. Please call the Information Gaithersburg Hilton, 620 Perry Pkwy., of the meeting. Line for up-to-date information on this Gaithersburg, MD. Notice of this meeting is given under meeting. Contact Person: Jan N. Johannessen, the Federal Advisory Committee Act (5 Agenda: The committee will discuss Office of Science and Health U.S.C. app. 2). the following items: (1) Updates and Coordination of the Office of the interactions with the Institute of Commissioner (HF–33), Food and Drug Dated: October 31, 2005. Medicine’s Air Force Health Study Administration, 5600 Fishers Lane (for Jason Brodsky, (AFHS) Disposition Study Committee; express delivery, rm. 14C–06), Acting Associate Commissioner for External (2) AFHS closure preparations; (3) Rockville, MD 20857, 301–827–6687, or Relations. updates from the Air Force on the AFHS by e-mail: jjohannessen@fda.gov or FDA [FR Doc. 05–22014 Filed 11–3–05; 8:45 am] history, program management, and the Advisory Committee Information Line, BILLING CODE 4160–01–S Comprehensive Study Report; (4)
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