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62126 Federal Register / Vol. 70, No. 208 / Friday, October 28, 2005 / Notices

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

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