32614 Federal Register / Vol. 74, No. 129 / Wednesday, July 8, 2009 / Notices 

registry are: (1) Continue to identify and 

enroll patients with CFS and other 

unexplained fatiguing illnesses who are 

receiving medical and ancillary medical 

care and describe their epidemiologic 

and clinical characteristics; (2) assess 

and monitor the health care providers’ 

knowledge, attitudes, and beliefs 

concerning CFS; (3) and to identify 

well-characterized CFS patients for 

future clinical studies and intervention 

trials. These specific aims require 

inclusion of subjects in early stages of 

CFS (i.e., ill less than one year duration) 

who can be followed longitudinally to 

assess changes in their CFS symptoms; 

persons with longer duration of fatigue 

will also be eligible. 

There is no cost to respondents other 

than their time. 

ESTIMATE OF ANNUALIZED BURDEN TABLE

Respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Total burden 

(hours) 

Referring Providers .......................................................................................... 200 2 5/60 33 

Patient consent to be contacted ...................................................................... 340 1 10/60 57 

Patient Telephone Interview ............................................................................ 289 1 44/60 212 

Patient Clinical Evaluation ............................................................................... 221 1 9 1,989 

Total Burden ............................................................................................. ........................ ........................ ........................ 2,291 

Dated: June 30, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–16141 Filed 7–7–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

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 July 23, 2009, from 8 a.m. to 

approximately 4 p.m. 

Location: Hilton Hotel Washington 

DC North/Gaithersburg, Montgomery 

Ballroom, 620 Perry Pkwy., 

Gaithersburg, MD 20877. 

Contact Person: Christine Walsh or 

Denise Royster, Center for Biologics 

Evaluation and Research, 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: The committee will discuss 

clinical trials to support use of vaccines 

against the 2009 H1N1 influenza virus. 

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/ 

AdvisoryCommittees/Calendar/ 

default.htm, click on the year 2009 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 July 16, 2009. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 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 July 15, 2009. 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 July 9, 2009. 

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/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.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: June 29, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–16099 Filed 7–7–09; 8:45 am] 

BILLING CODE 4160–01–S 

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