DATES: Submit written or electronic comments by November 24, 2008.
ADDRESSES: Submit written comments concerning this document to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
To ensure timelier processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail.
FOR FURTHER INFORMATION CONTACT: Binita Ashar or Long Chen, Center for Devices and Radiological Health (HFZ-500), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3600, e-mail: email@example.com or firstname.lastname@example.org.
The complete documents could be viewed either at FDA or ar Regulations.gov.