Temporary Deferment of Action on Certain Submissions
In an effort to upgrade CBER's database and tracking system for license applications, CBER is converting to a new database system starting in June 2000. Because of this conversion, CBER will be unable to start work or continue work on certain pending submissions and reports until conversion to the new system is ready.
Therefore, CBER plans to temporarily defer action on certain submissions including BLAs, PLAs, ELAs, and related correspondence.
CBER is requesting that applicants voluntarily refrain from filing the affected submissions during the conversion period, which will begin on June 26, 2000, and is expected to continue until July 20, 2000.
CBER will continue to accept mail during this period, but affected submissions and related correspondence will not be officially logged in nor will review of affected submissions or related correspondence begin.
Any review period will not begin until the conversion is completed and CBER review functions resume.
CBER will attempt to keep the mail in the order of the day received. When work resumes, it will be done according to the order that it was received.
The review periods on pending submissions will be suspended during the conversion period. The Action Due Date for all pending submissions will be extended by the length of the actual deferment.
CBER will attempt to minimize the period during which regular procedures are suspended.
Other submissions subject to CBER review and approval, including IND's, NDAs, 510ks, PMAs, or IDEs will not be affected by the conversion and temporary deferment.
Confirmation of the resumption of normal review procedures and any change in this timeframe will be announced on CBER's web site at http://www.fda.gov/cber/genadmin.htm.
Persons who may be affected by this temporary deferment should call CBER's Office of Communication, Training and Manufacturers Assistance, Manufacturers Assistance and Technical Training Branch, at 301-827-2000 with any questions regarding the conversion. Inquiries may also be sent via e-mail to matt@cber.fda.gov.
FEDERAL REGISTER: Temporary Deferment of Activities Relating to Certain Biological Submissions - 6/22/2000 (PDF, 123 KB)