Federal Register / Vol. 75, No. 210 / Monday, November 1, 2010 / Notices 67093 

Respondents (forms listed in parentheses) Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

General national sample of adults age 18+ (consent form) ............................ 1,650 1 2/60 55 

General national sample of adults age 18+ (full survey) ................................ 1,500 1 25/60 625 

Total .......................................................................................................... ........................ ........................ ........................ 770 

Carol Walker, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–27487 Filed 10–29–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Joint Meeting of the Anesthetic and 

Life Support Drugs Advisory 

Committee and the Drug Safety and 

Risk Management 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committees: Anesthetic and Life 

Support Drugs Advisory Committee and the 

Drug Safety and Risk Management Advisory 

Committee. 

General Function of the Committees: To 

provide advice and recommendations to the 

Agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on December 2, 2010, from 8 a.m. to 4:30 

p.m. 

Location: The Marriott Inn and Conference 

Center, University of Maryland University 

College, The Ballroom, 3501 University Blvd. 

East, Adelphi, MD. The hotel telephone 

number is 301–985–7300. 

Contact Person: Kalyani Bhatt, Center for 

Drug Evaluation and Research, Food and 

Drug Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, MD 

20993–0002, 301–796–9001, FAX: 301–847– 

8533, e-mail: kalyani.bhatt@fda.hhs.gov, or 

FDA Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), codes 3014512529 or 

3014512535. 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: On December 2, 2010, the 

committees will begin with a closed session 

from 8 a.m. to 9:15 a.m. Following the closed 

session, from 9:15 a.m. to 4:30 p.m., the 

meeting will be open to the public. The 

committees will discuss new drug 

application (NDA) 201655, Oxymorphone 

HCl Extended-Release Tablets, Endo 

Pharmaceuticals, Inc., and its safety for the 

proposed indication of relief of moderate to 

severe pain in patients requiring continuous, 

around-the-clock opioid treatment for an 

extended period of time. The extendedrelease characteristics of this formulation are 

purportedly less easily defeated than other 

formulations of controlled-release 

oxymorphone. 

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. Scroll down to the appropriate 

advisory committee link. 

Procedure: On December 2, 2010, from 9:15 

a.m. to 4:30 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 on or before November 17, 2010. 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 

November 8, 2010. 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 November 9, 2010. 

Closed Presentation of Data: On December 

2, 2010, from 8 a.m. to 9:15 a.m., the meeting 

will be closed to permit discussion and 

review of trade secret and/or confidential 

information (5 U.S.C. 552b(c)(4)). During this 

session, the committee will discuss 

confidential protocol and methodology. 

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 Kalyani 

Bhatt 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/ 

AdvisoryCommittees/ 

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: October 26, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–27457 Filed 10–29–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0517] 

Iceberg Water Deviating From Identity 

Standard; Temporary Permit for Market 

Testing 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a temporary permit has been issued 

to Iceberg Canada Corp., to market test 

a product designated as ‘‘GLACE Rare 

Iceberg Water’’ that deviates from the 

U.S. standard of identity for bottled 

water. The purpose of the temporary 

permit is to allow the applicant to 

measure consumer acceptance of the 

product, identify mass production 

problems, and assess commercial 

feasibility. 

DATES: This permit is effective for 15 

months, beginning on the date the 

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