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.
Persons should send submissions on paper or on electronic media (CD, DVD) and other regulatory correspondence to the Document Control Center at CBER’s new mailing address, as of May 12, 2014.
CBER’s new mailing address is:
U.S. Food and Drug Administration
Center for Biologics Evaluation and Research
Document Control Center
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- It is critical to address all regulatory correspondence to the CBER Document Control Center at the above White Oak address.
- Staff names should NOT be placed on the document packaging or envelope address for regulatory correspondence. Addressing documents to individual staff members, Division or Branch Directors or simply a Branch or Division will result in a delay in CBER officially receiving the documents, and a possible delay in review, assigning meetings, or other regulatory activities.
- Regulatory documents delivered by couriers should be delivered to the CBER Document Control Center in Room G112 on the ground floor of building 71.
- The CBER Document Control Center is open and will accept documents from 8:00 to 4:30 EST
Sending Lot Release Samples
CBER’s Sample Custodian (the person(s) responsible for receiving official lot release samples) is scheduled to move to the FDA White Oak campus in Silver Spring, Maryland on Monday, August 11, 2014. Due to unforeseen circumstances, receipt of lot release samples at the new White Oak campus has been delayed until Tuesday, September 2, 2014. This extended pause will allow us to ensure the orderly transfer of lot release samples to the FDA White Oak campus in the weeks immediately before and after the move.
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: