Rivulet Media Inc (fka RIVU)

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BMSN
You can bet this didn't help the FDA's (CBER) turn around time in an already, very slow bureaucratic process.

[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12506-12507]
From the Federal Register Online via the Government Printing 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