The Federal Register

Medical Devices; Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

Tue, Nov 18 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile flow generator, and the ocular plethysmograph. The agency also is summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements and the benefits to the public from the use of the devices. In addition, FDA is announcing the opportunity for interested persons to request that the agency change the classification of any of the devices based on new information. This action implements certain statutory requirements.

Determination That Diclofenac Potassium 25-Milligram Tablet Was Not Withdrawn From Sale for Reasons of Safety or

Tue, Nov 18 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing its determination that diclofenac potassium 25milligram (mg) tablet (Cataflam) was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for diclofenac potassium 25mg tablet.

Anesthetic and Life Support Drugs Advisory Committee; Amendment of Notice

Tue, Nov 18 2003 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Anesthetic and Life Support Drugs Advisory Committee. This meeting was announced in the Federal Register of October 8, 2003 (68 FR 58115). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

Tue, Nov 18 2003 11:00:00 GMT

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 December 8, 2003, from 8:30 a.m. to 5 p.m. and on December 9, 2003, from 8 a.m. to 4:30 p.m.

Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Dornette SpellLeSane, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 3018277001, FAX: 3018276776, email: spelllesaned@cder.fda.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572) in the Washington, DC area), code 12533. Please call

Drug Safety and Risk Management Advisory Committee; Notice of Meeting

Tue, Nov 18 2003 11:00:00 GMT

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: Drug Safety and Risk Management Advisory Committee.

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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 December 4, 2003, from 8 a.m. to 5 p.m.

Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD.

Contact Person: Shalini Jain, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 3018277001, email: jains@cder.fda.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 12535. Please call the Information Line for up to date information on this meeti

Food Advisory Committee; Notice of Meeting

Tue, Nov 18 2003 11:00:00 GMT

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: Food 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 December 10, 2003, from 9:30 a.m. until 4:30 p.m. and on December 11, 2003, from 8:30 a.m. to 4 p.m.

Location: Hotel Washington, Pennsylvania Ave. at 15th St. NW., Washington, DC 200041099.

Contact Person: Catherine M. DeRoever, Center for Food Safety and Applied Nutrition (HFS006), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD, 3014362397, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 10564. Please call the Information Line for uptodate information on this meeting.

Agenda: The purpose of the meeting is to review reports of the Dietary

Oncologic Drugs Advisory Committee; Notice of Meeting

Tue, Nov 18 2003 11:00:00 GMT

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: Oncologic 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 December 16, 2003, from 8 a.m. to 5 p.m.

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Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., Bethesda, MD.

Contact Person: Johanna M. Clifford, Center for Drug Evaluation and Research (HFD21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 3018277001, FAX: 3018276776 or email: cliffordj@cder.fda.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area), code 12542. Please call the Information Line for uptodate information on