About FDA

CBER HAS MOVED

In an effort to consolidate, FDA has moved the offices and laboratories of the Center for Biologics Evaluation and Research (CBER) from their locations in Bethesda and Rockville, Maryland to the FDA White Oak campus in Silver Spring, Maryland.  The move took place during the spring and summer of 2014 and is now complete. 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 is provided on this page.

Submission of Regulatory Submissions

Persons are encouraged 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
CBER’s NEW 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

Adverse Events information should be reported electronically or for paper reports mailed to specified addresses but not to CBER Document Control Center. 

Submission of Lot Release Samples and Lot Release Protocols

Official lot release samples should be sent to the CBER’s Sample Custodian new address listed below.

Electronic lot release protocols can be submitted through the FDA Gateway at any time.

Lot release protocols submitted in paper or CD-ROM electronic format should be sent to the new CBER Sample Custodian address.

New Sample Custodian Address at White Oak Campus
Food and Drug Administration
Center for Biologics Evaluation and Research
Sample Custodian
10903 New Hampshire Avenue
WO75-G707
Silver Spring, MD 20993-0002

For updated information on Lot Release please see:

http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ucm345223.htm

Contacts at CBER

Additional information on contacts at CBER can be found at
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm106001.htm

Contact information for staff can be found at http://directory.psc.gov/employee.htm

CBER General Numbers and the CBER Key Staff Directory can be found at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123224.htm     

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 Buildings 71, and 52 in the Southeast Quadrant of the campus.    All visitors should park in the North West Surface Parking Lot and enter through building #1.

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

Page Last Updated: 10/07/2014
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