FDA will begin its multi-week process to move personnel into new buildings on the White Oak campus later this month, somewhat earlier than initially expected.

The Center for Biologics Evaluation and Research and Office of Generic Drugs will begin moving from sites in the Washington D.C. area to the agency’s Silver Spring, Md. headquarters in late April.

CBER announced most of its offices will move from about April 25 through May 18, according to its website dedicated to the relocation. Some laboratories and other offices will move in late June through August.

OGD’s move will be staggered and run about the same time, from late April to the end of May, the agency said in an April 14 email. The office has not announced a formal relocation schedule.

CBER Relocation Schedule

Most offices: April 25-May 18
Labs and offices not in above group: late June through August
Office of Compliance and Biologics Quality’s Division of Biological Standards and Quality Control: after processes assuring 2014-2015 seasonal flu vaccine availability are completed

Source: FDA

Acting OGD Director Kathleen Uhl had said the move was expected between March and August ([A#00130715007]).

The CBER schedule also will begin somewhat earlier and finish later than the May 1 through July 1 estimated schedule it gave in a March Federal Register notice.

The Division of Biological Standards and Quality Control within CBER’s Office of Compliance and Biologics Quality will remain at its Kensington, Md. location until “processes assuring the availability of 2014-2015 seasonal influenza virus vaccine are completed” to facilitate continuity of operations, according to the website.

An FDA advisory committee decided to not change the seasonal flu vaccine strains in 2014-2015 despite concerns about efficacy rates ([A#14140228005]).

Two-Week Pause On Lot Release Samples Submissions

The CBER review staff is moving to Building 71 at White Oak, which is part of the new Life Sciences-Biodefense Laboratory complex, a quad of buildings on the southeast corner of the sprawling campus. Building 75 will be the main entrance to the quad, which also includes buildings 52 and 72.

OGD will be located in Building 75.

Sponsor meetings with CBER may be in the new building or another location within White Oak. The agency said regulatory project managers will inform sponsors of new meeting locations.

Most staff phone and fax numbers also will change as a result of the move, but email addresses will not. Existing phone numbers will include a message with the new contact information for about 60 days after the move, according to the website. During the move, FDA said the best way to reach CBER staff will be via email.

Staff directories on the FDA and Department of Health and Human Services websites also will be updated as contact information changes.

CBER will not be able to receive lot release samples during a two-week period when its sample custodian is relocated. Sponsors should either ship samples to CBER’s existing address before the pause or send samples to the new White Oak address after it is concluded.

The exact date of this interruption has not been released, but the agency said CBER would talk with manufacturers that will be affected.

The center will continue to receive lot release protocols during the interruption, according to the website.

It will continue receiving applications and other submissions via the FDA electronic gateway throughout the move. Submissions sent on paper or via CD or DVD still should be sent to the CBER Document Control Center’s existing address in Rockville, Md.

A new address for regulatory submissions and other mail is expected to be announced in early May once the document control center begins its relocation, according to the website.

CBER also said it hopes to minimize application review and receipt delays caused by the move.

White Oak Master Plan Still Not Complete

The Life Sciences-Biodefense Laboratory is nearly completed after more than three years of construction. The quad is expected to support annual and pandemic flu preparedness and blood supply and biological product protection Also see "FDA FY 2012 Budget Gives Hamburg Regulatory Science Upgrade A Year Late" - Pink Sheet, 21 February, 2011..

While the existing phase of White Oak construction is nearing completion, the schedule for some remaining buildings remains unclear.

Designs for buildings 25, 45, and a communications center were put on hold because construction funds were not available Also see "Revising The Blueprint: FDA HQ Construction Nears Completion, But Some Planned Buildings On Hold" - Pink Sheet, 20 February, 2012..

President Obama also cut the funds devoted to White Oak construction in his FY 2015 budget request, but increased the amount going to rent payments Also see "FDA Winding Down White Oak Construction; Outside Rents Going Up" - Pink Sheet, 10 March, 2014..

FDA Commissioner Margaret Hamburg said funding that had been earmarked for construction would pay for the agency’s FY 2015 expansion of compounding oversight ([A#14140327004]).

CBER To Pause Receipt Of Lot Release Samples During Move To White Oak

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