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U.S. Department of Health and Human Services

About FDA

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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.
 
During the time of the move, persons are encouraged and should continue to send applications and other regulatory submissions electronically via the FDA Electronic Submissions Gateway to CBER.  For information on electronic submissions see http://www.fda.gov/biologicsbloodvaccines/developmentapprovalprocess/ucm163685.htm
 
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
            WO71, G112
            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

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:
http://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.
 
Contact information for staff can be found at http://directory.psc.gov/employee.htm . This information will be updated periodically to reflect new information as staff move. 
 
CBER General Numbers and the CBER Key Staff Directory http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123224.htm will be updated periodically to reflect White Oak phone numbers as staff move.   
 
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:
 
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm