[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12506-12507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04810]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0225]


Announcement of Center for Biologics Evaluation and Research's 
Move to the Food and Drug Administration's White Oak Campus

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
Center for Biologics Evaluation and Research (CBER) will be moving its 
offices and laboratories from various Rockville and Bethesda, MD, 
locations to the FDA White Oak campus in Silver Spring, MD. The move 
will commence on or about May 1, 2014, and will end approximately 8 
weeks later, on or about July 1, 2014. During this time persons may 
continue to send applications and other submissions electronically via 
the FDA Electronic Submissions Gateway to CBER for review, evaluation, 
or other handling. However, persons should send submissions on paper or 
on electronic media (CD, DVD), as well as lot release samples to CBER's 
new mailing addresses once they take effect. CBER's new mailing 
addresses, including the dates they take effect, as well as other 
information concerning CBER's move to the FDA White Oak campus in 
Silver Spring, MD, will be provided on the FDA Web site at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm, as they become available. During the period 
required for relocation of files, equipment, and Agency personnel, CBER 
will make every effort to meet its review time frames and minimize any 
potential

[[Page 12507]]

delay. Should delays affecting receipt and review of applications and 
other submissions occur, we intend to update the FDA Web site as 
needed.

FOR FURTHER INFORMATION CONTACT: John Reilly, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 201 et 
seq.) and section 351 of the Public Health Service Act (42 U.S.C. 262), 
CBER is responsible for receiving, reviewing, evaluating, and taking 
appropriate actions on a variety of regulated activities, including but 
not limited to:
    (1) Investigational new drug applications and investigational 
device exemption applications for certain products for which CBER has 
been assigned responsibility;
    (2) Biologics license applications submitted for biological 
products;
    (3) New drug applications, abbreviated new drug applications, 
premarket approval applications, and premarket notifications for which 
CBER has been assigned responsibility; and
    (4) Protocols and samples submitted for official release (lot 
release).
    In an effort to consolidate, FDA is moving CBER's offices and 
laboratories from various Rockville and Bethesda, MD, locations to the 
FDA White Oak campus in Silver Spring, MD. The move will commence on or 
about May 1, 2014, and will end approximately 8 weeks later, on or 
about July 1, 2014. During this time, persons may continue to send 
applications and other submissions electronically via the FDA 
Electronic Submissions Gateway to CBER for review, evaluation, or other 
handling. However, persons should send submissions on paper or on 
electronic media (CD, DVD) (including lot release protocols) to CBER's 
new mailing addresses once they take effect. CBER's new mailing 
addresses, including the dates they take effect, as well as other 
information concerning CBER's move to the FDA White Oak campus in 
Silver Spring, MD, will be provided on the FDA Web site at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm as they become available.
    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 address, or (2) after the 
pause, using the new address once it takes effect. See the FDA Web site 
at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm for the dates of 
this pause. We also plan to communicate directly with those 
manufacturers affected by this temporary interruption in CBER's receipt 
of lot release samples.
    During the period required for relocation of files, equipment, and 
Agency personnel, CBER will make every effort to meet its review time 
frames and minimize any potential delay. Should delays affecting 
receipt and review of applications and other submissions occur, we 
intend to update the FDA Web site as needed.

II. Comments

    Persons who have questions or wish further information concerning 
CBER's move to the FDA White Oak campus in Silver Spring, MD, may 
access the FDA Web site at http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm for more 
information. CBER intends to update this Web site periodically.

    Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04810 Filed 3-4-14; 8:45 am]
BILLING CODE 4160-01-P