Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Food and Drug Administration

# 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