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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Oncologic Drugs Advisory Committee; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of the meeting of the 

Oncologic Drugs Advisory Committee. 

This meeting was announced in the 

Federal Register of October 14, 2005 (70 

FR 60094). The amendment is being 

made to reflect changes in the Agenda 

portion of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: 

Johanna 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 or email: cliffordj@cder.fda.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 14, 2005, 

FDA announced that a meeting of the 

Oncologic Drugs Advisory Committee 

will be held on November 8, 2005. On 

page 60094, beginning in the third 

column, and continuing on page 60095, 

the Agenda portion of the meeting is 

amended to read as follows: 

Agenda: The committee will discuss 

new drug applications approved under 

21 CFR 314.500 and 601.40 (subparts H 

and subpart E, respectively, accelerated 

approval regulations) in an open session 

to do the following: (1) Review the 

status of phase IV clinical studies; (2) 

identify difficulties associated with 

completion of phase IV commitments; 

and (3) provide advice to sponsors to 

assist in the planning and execution of 

postmarketing commitments of newly 

approved drugs. The committee will 

discuss phase IV commitments of: (1) 

New drug application (NDA) 50–718, 

DOXIL (doxorubicin hydrochloride 

liposome injection, Johnson and 

Johnson Pharmaceutical Research and 

Development, L.L.C.) for the treatment 

of acquired immune deficiency 

syndrome (AIDS) related Kaposi’s 

sarcoma in patients with disease that 

has progressed on prior combination 

therapy or in patients who are intolerant 

to such therapy; (2) biologics license 

application (BLA) 103767/0, ONTAK 

(denileukin diftitox, Seragen 

Incorporated) for the treatment of 

patients with persistent or recurrent 

cutaneous T-cell lymphoma whose 

malignant cells express the CD25 

component of the interleukin-2 receptor; 

(3) NDA 21–041, DEPOCYT (cytarabine 

liposome injection, SkyePharma Inc.) 

for the intrathecal treatment of 

lymphomatous meningitis; (4) NDA 21–

156, CELEBREX (celecoxib capsules, 

Pfizer Inc.) for reducing the number of 

adenomatous colorectal polyps in 

familial adenomatous polyposis (FAP), 

as an adjunct to usual care (e.g., 

endoscopic surveillance, surgery); (5) 

NDA 21–174, MYLOTARG 

(gemtuzumab ozogamicin for injection, 

Wyeth Pharmaceuticals, Inc.) for the 

treatment of patients with CD33 positive 

acute myeloid leukemia in first relapse 

who are 60 years of age or older and 

who are not considered candidates for 

other cytotoxic chemotherapy; and (6) 

BLA 103948/0, CAMPATH 

(alemtuzumab, ILEX Pharmaceuticals, 

L.P.) for the treatment of B-cell chronic 

lymphocytic leukemia (B–CLL) in 

patients who have been treated with 

alkylating agents and who have failed 

fludarabine therapy. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: October 21, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–21493 Filed 10–27–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0410] 

Prescription Drug User Fee Act; Public 

Meeting; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

that appeared in the Federal Register of 

October 18, 2005 (70 FR 60536). The 

document announced a public meeting 

on the Prescription Drug User Fee Act 

(PDUFA). The document was published 

with typographical errors in the DATES

and FOR FURTHER INFORMATION CONTACT

sections of the document. This 

document corrects those errors. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Strong, Office of Policy (HF–27), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–7010. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

05–20875, appearing on page 60536 in 

the Federal Register of Tuesday, 

October 18, 2005, the following 

corrections are made: 

1. On page 60536, in the second 

column, the third sentence under DATES

is corrected to read: ‘‘You may register 

electronically at 

CBERTrainingSuggestions 

@cber.fda.gov.’’

2. On page 60536, in the second 

column, in the FOR FURTHER

INFORMATION CONTACT section, beginning 

in the fifth line, the telephone number 

‘‘301–827–2647’’ is corrected to read 

‘‘301–827–5902’’. 

Dated: October 20, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21525 Filed 10–27–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Psychopharmacologic 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: 

Psychopharmacologic 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 December 2, 2005, from 8 a.m. 

to 5 p.m. 

Location: Hilton, The Ballrooms, 620 

Perry Pkwy., Gaithersburg, MD, 301–

977–8900. 

Contact Person: Cicely Reese, 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: 

ReeseCi@cder.fda.gov, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512544. Please call the Information 

Line for up-to-date information on this 

meeting. The background material will