CBER IS MOVING
In an effort to consolidate, FDA is moving the offices and laboratories of the Center for Biologics Evaluation and Research (CBER) from their present locations in Bethesda and Rockville, Maryland to the FDA White Oak campus in Silver Spring, Maryland. Most offices will commence moving on or about April 25, 2014, and will complete the move approximately five weeks later, on or about May 18, 2014. Laboratories and remaining offices are scheduled to move in late June through August. In order to facilitate continuity of operations, one division, the Division of Biological Standards and Quality Control, within the Office of Compliance and Biologics Quality, will remain in its present location at 5516 Nicholson Lane, Building B, Kensington Md. 20895 and move after processes assuring the availability of 2014-2015 seasonal influenza virus vaccine are completed.
The announcement of CBER’s move to the FDA White Oak campus was published in the Federal Register on March 5, 2014 (79 FR 12506). Additional information on several topics is provided on this page. This page will be updated with information regarding CBER’s move to the FDA White Oak campus as it becomes available.
Review of Regulatory Submissions
During the move, CBER will make every effort to conduct its business with minimal disruption. This includes making efforts to meet review time frames and to minimize any potential delays. Should delays affecting receipt and review of applications and other submissions occur, we intend to update this Website if needed.
Sending Regulatory Submissions and Correspondence
Persons should send submissions on paper or on electronic media (CD, DVD) and other regulatory correspondence to the Document Control Center. The CBER Document Control Center will continue to accept regulatory documents at its current address (listed below) until a notice of address change is posted on this web site.
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center, HFM-99
1401 Rockville Pike, Suite 200N,
Rockville, Md. 20852-1448
It is expected that the notice of new address for regulatory submissions and other mail will be posted on this web site in early May, when the CBER Document Control Center begins moving.
Sending Lot Release Samples
Lot release samples should be sent to the appropriate new mailing address when it takes effect. Please note, however, that because of the relocation of CBER’s Sample Custodian (the person(s) responsible for receiving official samples, including lot release samples) to the FDA White Oak campus, CBER will not be able to receive lot release samples during the 2 weeks surrounding this personnel move. This pause will allow us to assure the orderly transfer of lot release samples to the FDA White Oak campus in the weeks immediately before and after this move. Therefore, lot release samples should be shipped to CBER either (1) before the pause, using the current Nicholson Lane address for CBER’s Sample Custodian, or (2) after the pause, using the new White Oak address for the Sample Custodian once it takes effect. This pause does not involve or impact CBER’s ability to receive lot release protocols.
For updated information on the exact dates of the pause and the new White Oak address for the Sample Custodian, please see: www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ucm345223.htm
CBER also plans to communicate directly with those manufacturers affected by this temporary interruption in CBER’s receipt of lot release samples.
Contacting CBER Staff
While staff e-mail addresses remain the same, most phone numbers will change. After staff move, their current phone numbers will have a message providing a new contact phone numbers for approximately 60 days. However, during this time, the best way to reach CBER staff is by e-mail asoffice addresses, phone and fax numbers will change.
Meetings at White Oak Campus
The White Oak campus is located at 10903 New Hampshire Avenue, Silver Spring, MD 20993 CBER review staff are located in Building 71 in the Southeast Quadrant of the campus. The main entrance to the Southeast Quadrant is through Building 75, which is adjacent to the Southeast Quadrant Surface Parking Lot.
For persons attending meetings scheduled with CBER, the assigned Regulatory Project Manager will provide information, as meetings may possibly take place in another location on the White Oak campus.
Information about attending public meetings held in Building 31 “The Great Room” at White Oak (includes general questions on traveling to White Oak) can be found at: