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,