60094 Federal Register / Vol. 70, No. 198 / Friday, October 14, 2005 / Notices 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014519516. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On November 3, 2005, in the 

morning, the committee will hear 

updates on the following topics: (1) 

West Nile Virus; (2) draft guidance on 

nucleic acid testing (NAT) for human 

immunodeficiency virus (HIV)–1 and 

hepatitis C virus (HCV): Testing, 

product disposition, and donor deferral 

and re-entry; (3) summary of the 

Department of Health and Human 

Services Advisory Committee on Blood 

Safety and Availability held on 

September 19 and 20, 2005; and (4) reentry of donors deferred based on 

hepatitis B core antigen (anti-HBc) test 

results. The committee will discuss 

approaches to over-the-counter (OTC) 

home-use HIV test kits the rest of the 

day. On November 4, 2005, in the 

morning, the committee will hear 

information on serious adverse events 

resulting from interference with 

measurement of blood glucose following 

infusion of maltose-containing immune 

globulin intravenous (human) and will 

discuss Alpha-1-Proteinase Inhibitor 

products. In the afternoon, the 

committee will hear an overview of the 

research programs of the Office of Blood 

Research and Review, Center for 

Biologics Evaluation and Research, as 

presented to a subcommittee of the 

Blood Products Advisory Committee 

during their site visit on July 22, 2005, 

and discuss a subcommittee report. 

Procedure: On November 3, 2005, the 

entire meeting is open to the public. On 

November 4, 2005, from 8 a.m. to 2:15 

p.m. the meeting is open to the public. 

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 October 

25, 2005. Oral presentations from the 

public will be scheduled on November 

3, 2005, between approximately 2 p.m. 

and 3:45 p.m. and on November 4, 2005, 

between 10:30 a.m. and 11 a.m. Time 

allotted for each presentation may be 

limited. Those desiring to make formal 

oral presentations should notify the 

contact person before October 25, 2005, 

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. 

Closed Committee Deliberations: On 

November 4, 2005, from 2:15 p.m. to 3 

p.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)), and to permit discussion 

and review of trade secret and/or 

confidential information (5 U.S.C. 

552b(c)(4)). The committee will discuss 

a subcommittee’s report of the internal 

research programs in the Office of Blood 

Research and Review, CBER. 

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 Donald W. 

Jehn or Pearline K. Muckelvene 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: October 6, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–20560 Filed 10–13–05; 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 is 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 November 8, 2005, from 8 a.m. to 

5 p.m. 

Location: Holiday Inn, The Ballrooms, 

Two Montgomery Village Ave., 

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 

(ODAC).’’ (Click on the year 2005 and 

scroll down to ODAC meetings.) 

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) NDA 20–221/S–002, 

ETHYOL for injection (amifostine, 

MedImmune Oncology, Inc.) for 

reducing the cumulative renal toxicity 

associated with repeated administration 

of cisplatin in patients with advanced 

nonsmall cell lung cancer; (3) 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; 

(4) NDA 21–041, DEPOCYT (cytarabine 

liposome injection, SkyePharma Inc.) 

for the intrathecal treatment of 

lymphomatous meningitis; and (5) NDA 

21–156, CELEBREX (celecoxib capsules, 

Pfizer, Inc.) for reducing the number of 

adenomatous colorectal polyps in 

familial adenomatous polyposis, as an 

adjunct to usual care (e.g., endoscopic 

surveillance, surgery); (6) NDA 21–174, 

MYLOTARG (gemtuzumab ozogamicin 

for injection, Wyeth Pharmaceuticals, 

Inc.) for the treatment of patients with 

CD33 positive acute myeloid leukemia 

Federal Register / Vol. 70, No. 198 / Friday, October 14, 2005 / Notices 60095 

in first relapse who are 60 years of age 

or older and who are not considered 

candidates for other cytotoxic 

chemotherapy; and (7) 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. 

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 November 1, 2005. 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 November 1, 2005, 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: October 6, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–20559 Filed 10–13–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Transmissible Spongiform 

Encephalopathies 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: Transmissible 

Spongiform Encephalopathies 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 October 31, 2005, from 8 a.m. 

to 5:30 p.m. 

Location: Holiday Inn Select, 8120 

Wisconsin Ave., Bethesda, MD. 

Contact Person: William Freas or 

Sheila D. Langford, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512392. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: On October 31, 2005, the 

committee will hear updates on the 

following topics: Current status of 

bovine spongiform encephalopathy 

(BSE) in the United States, incidence 

and prevalence worldwide of variant 

Creutzfeldt-Jakob Disease (vCJD), and a 

summary of FDA’s device panel 

discussion on September 27, 2005, on 

criteria for considering label claims of 

effective decontamination for surgical 

instruments exposed to transmissible 

spongiform encephalopathy (TSE) 

agents. The committee will then discuss 

progress in development of a risk 

assessment model for vCJD in U.S.- 

licensed human plasma-derived 

Antihemophilic Factor (Factor VIII). The 

latter discussion will focus on selection 

of input parameters for the model. In the 

afternoon, the committee will discuss 

labeling claims for TSE clearance 

studies for blood component filters. 

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 October 21, 2005. Oral 

presentations from the public will be 

scheduled between approximately 12:30 

p.m. and 1 p.m., and 4:15 p.m. and 4:45 

p.m. on October 31, 2005. Time allotted 

for each presentation may be limited. 

Those desiring to make formal oral 

presentations should notify the contact 

person before October 25, 2005, 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 William 

Freas or Sheila Langford 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: October 6, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–20558 Filed 10–13–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2005–22613] 

National Maritime Security Advisory 

Committee 

AGENCY: U.S. Coast Guard, DHS. 

ACTION: Notice of meeting. 

SUMMARY: The National Maritime 

Security Advisory Committee (NMSAC) 

will hold a meeting to discuss various 

issues relating to national maritime 

security. This notice announces the 

date, time, and location for the meeting 

of the NMSAC. 

DATES: NMSAC will meet on Tuesday, 

November 1, 2005, from 8:30 a.m. to 

3:30 p.m. The meeting may close early 

if all business is finished. Written 

material and requests to make oral 

presentations should reach the Coast 

Guard on or before October 21, 2005. 

Any material requested to be distributed 

to each member of the Committee 

should reach the Coast Guard on or 

before October 24, 2005. 

ADDRESSES: NMSAC will meet in Room 

329 at the George Mason University 

School of Law, 3401 North Fairfax 

Drive, Arlington, VA 22201. Send 

written material and requests to make 

oral presentations to Mr. John Bastek, 

Commandant (G–MPS–2), U.S. Coast 

Guard Headquarters, 2100 Second St. 

SW., Washington, DC 20593–0001. This 

notice is available on the Internet at 

http://dms.dot.gov. 

FOR FURTHER INFORMATION CONTACT: Mr. 

John Bastek, Executive Secretary,