Federal Register / Vol. 70, No. 178 / Thursday, September 15, 2005 / Notices 54559 

Dated: September 9, 2005. 

William P. Nichols, 

Director, Procurement and Grants Office, 

Centers for Disease Control and Prevention. 

[FR Doc. 05–18321 Filed 9–14–05; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004N–0486] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Experimental Study of Health Claims 

on Food Packages 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Experimental Study of Health Claims 

on Food Packages’’ has been approved 

by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 20, 2005 (70 

FR 20568), the agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0565. The 

approval expires on August 31, 2008. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: September 7, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–18283 Filed 9–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Cardiovascular and Renal 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 Committee: Cardiovascular 

and Renal Drugs 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 November 16, 2005, from 8 a.m. 

to 5 p.m. 

Location: Food and Drug 

Administration, CDER Advisory 

Committee Conference Room, rm. 1066, 

5630 Fishers Lane, Rockville, MD. 

Contact Person: Cathy Groupe, 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 FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512533. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The committee will discuss 

new drug application (NDA) 21–628, 

proposed trade name CERTICAN 

(everolimus) Tablets (0.25 milligrams 

(mg), 0.50 mg, 0.75 mg, and 1.0 mg), 

Novartis Pharmaceuticals Corporation, 

for the proposed indication of 

prophylaxis of rejection in heart 

transplantation. The background 

material will become available no later 

than the day before the meeting and will 

be posted on FDA’s Web site at http:// 

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

acmenu.htm. (Click on the year 2005 

and scroll down to the heading 

Cardiovascular and Renal Drugs 

Advisory Committee.) 

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 8, 2005. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Time allotted for each 

presentation may be limited. Those 

desiring to make formal oral 

presentations should notify the contact 

person before November 8, 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 Beverly 

O’Neil at 301–827–7001, 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: September 6, 2005. 

Scott Gottlieb, 

Deputy Commissioner for Policy. 

[FR Doc. 05–18365 Filed 9–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Dental Products 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: Dental Products 

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 October 11, 2005, from 9:15 

a.m. to 5:45 p.m., and on October 12, 

2005, from 8 a.m. to 5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Ballroom Salons A 

and B, 620 Perry Pkwy., Gaithersburg, 

MD. 

Contact Person: Michael E. Adjodha, 

Center for Devices and Radiological 

Health (HFZ–480), Food and Drug