2011-20644. Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of July 14, 2011 (76 FR 41507). The amendment is being made to reflect a change in the Procedure portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT:

Shanika Craig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993-0002, 301-796-6639, [e-mail], or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION:

In the Federal Register of July 14, 2011, FDA announced that a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee would be held on September 8 and 9, 2011. On page 41508, in the first column, the Procedure section is changed to add, directly after the first full paragraph, the following paragraph:

FDA will work with the manufacturers of surgical mesh products who wish to make presentations to ensure that adequate time, separate from the 10 a.m. to 11 a.m. time slots from the general open public hearing, is provided. Manufacturers interested in making formal presentations to the committee should notify the contact person on or before August 22, 2011. Manufacturers with common interest are urged to coordinate their oral presentations.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

Dated: August 9, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.