Federal Register / Vol. 69, No. 236 / Thursday, December 9, 2004 / Notices 71419

Inc., at 12th and Lincoln Sts. SW., Le 

Mars, IA 51031. The test products will 

be distributed by Wells’ Dairy, Inc., 

throughout the States of Iowa, 

Minnesota, Wisconsin, Missouri, 

Nebraska, Oklahoma, Kansas, South 

Dakota, North Dakota, Arkansas, and 

Colorado. Each of the ingredients used 

in the food must be declared on the 

labels as required by the applicable 

sections of part 101 (21 CFR part 101). 

The information panel of the labels will 

bear nutrition labeling in accordance 

with § 101.9. This permit is effective for 

15 months, beginning on the date the 

permit holder introduces or causes the 

introduction of the product into 

interstate commerce, but not later than 

March 9, 2005.

Dated: November 29, 2004. 

Barbara Schneeman, 

Director, Office of Nutritional Products, 

Labeling and Dietary Supplements, Center for 

Food Safety and Applied Nutrition.

[FR Doc. 04–26996 Filed 12–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Circulatory System Devices Panel of 

the Medical Devices 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: Circulatory 

System Devices Panel of the Medical 

Devices 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 January 13, 2005, from 9 a.m. 

to 5 p.m. 

Location: Hilton Washington DC 

North, The Ballrooms, 620 Perry Pkwy., 

Gaithersburg, MD. 

Contact Person: Geretta Wood, Center 

for Devices and Radiological Health 

(HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 301–443–8320, 

ext. 143, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512625. Please call the 

Information Line for up-to-date 

information on this meeting. 

Agenda: The committee will hear a 

presentation on the FDA Critical Path 

Initiative. The committee will also 

discuss, make recommendations, and 

vote on a premarket approval 

application for a thoracic 

endoprosthesis intended for 

endovascular repair of the descending 

thoracic aorta. 

Background information for the 

topics, including the agenda and 

questions for the committee, will be 

available to the public 1 business day 

before the meeting on the Internet at 

http://www.fda.gov/cdrh/

panelmtg.html. 

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 January 5, 2005. Oral 

presentations from the public will be 

scheduled for approximately 30 minutes 

at the beginning of committee 

deliberations and for approximately 30 

minutes near the end of the 

deliberations. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before January 5, 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 AnnMarie 

Williams, at 301–594–1283, ext. 113, 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: December 1, 2004. 

Sheila Dearybury Walcoff, 

Associate Commissioner for External 

Relations.

[FR Doc. 04–26994 Filed 12–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Joint Meeting of the Nonprescription 

Drugs Advisory Committee and the 

Endocrinologic and Metabolic 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 will be open to the 

public. 

Name of Committees: 

Nonprescription Drugs Advisory 

Committee (NDAC) and the 

Endocrinologic and Metabolic Drugs 

Advisory Committee (EMDAC). 

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 January 13, 2005, from 8 a.m. 

to 5 p.m., and January 14, 2005, from 8 

a.m. to 3 p.m. 

Location: Holiday Inn, Versailles 

Ballrooms, 8120 Wisconsin Ave., 

Bethesda, MD 20814. 

Contact Person: Cathy A. Groupe, or 

Hilda F. Scharen, 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, e-mail 

GroupeC@cder.fda.gov or 

scharenh@cder.fda.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), codes 

3014512541 and 3014512536. Please 

call the Information Line for up-to-date 

information on this meeting. 

Agenda: On both days, the 

committees will consider the safety and 

efficacy of new drug application (NDA) 

21–213, proposing over-the-counter 

(OTC) use of MEVACOR (lovastatin), 20 

milligrams a day, Merck & Co., Inc., to 

help lower LDL ‘‘bad’’ cholesterol, 

which may prevent a first heart attack. 

The background material will become 

available no later than the day before 

the meeting and will be posted under 

the NDAC or the EMDAC Docket site at 

http://www.fda.gov/ohrms/dockets/ac/

acmenu.htm (click on the year 2005 and 

scroll down to NDAC or EMDAC). 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written