51492 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.regulations.gov, http:// 

www.fda.gov/cder/guidance/index.htm, 

or http:www/fda.gov/cber/ 

guidelines.htm. 

Dated: August 26, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20294 Filed 9–2–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Vaccines and Related Biological 

Products 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: Vaccines and 

Related Biological Products 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 September 25, 2008, from 8:30 

a.m. to approximately 4 p.m. 

Location: Crowne Plaza Hotel, 8777 

Georgia Ave., Silver Spring, MD 20910 

Contact Person: Christine Walsh or 

Denise Royster, 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 

3014512391. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: In open session the 

Committee will be briefed on the Office 

of Vaccine’s Research and Review 

(OVRR), Center for Biologics Evaluation 

and Research (CBER) response to OVRR 

Office Site Visit Review Report that was 

presented and approved by this 

committee on January 25, 2007. The 

Committee will also hear presentations 

and hold discussion on the use of 

Madin-Darby canine kidney (MDCK) 

Cells for manufacture of live attenuated 

Influenza Virus Vaccines. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 and scroll down to the 

appropriate advisory committee link. 

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 on or before September 18, 2008. 

Oral presentations from the public will 

be scheduled between approximately 2 

p.m. and 3 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person 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 on 

or before September 8, 2008. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

September 11, 2008. 

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 Christine 

Walsh or Denise Royster at least 7 days 

in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: August 27, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–20372 Filed 9–2–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Heritable 

Disorders in Newborns and Children; 

Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Public Law 92–463), notice is hereby 

given of the following meeting: 

Name: Advisory Committee on 

Heritable Disorders in Newborns and 

Children (ACHDNC). 

Dates and Times: October 1, 2008, 1 

p.m. to 5 p.m.; October 2, 2008, 8 a.m. 

to 3 p.m. 

Place: Capital Hilton, 1001 16th 

Street, NW., Washington, DC 20036. 

Status: The meeting will be open to 

the public with attendance limited to 

space availability. Participants are asked 

to register for the meeting by going to 

the registration Web site at http:// 

events.SignUp4.com/ACHDNC1008. 

Individuals who need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should indicate their 


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