[Federal Register Volume 59, Number 184 (Friday, September 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-23617]
[[Page Unknown]]
[Federal Register: September 23, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Termination of Temporary Deferment of Activities Relating to
Biologics Submissions and Notice of New Mailing Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the new
address for submissions and identifying the exact period which action
on pending submissions was temporarily deferred. In a notice published
in the Federal Register of January 13, 1993 (58 FR 4173), FDA announced
that the Document Control Center of the Center for Biologics Evaluation
and Research (CBER) moved from various locations in Rockville and
Bethesda, MD to the Woodmont Office Center, 1401 Rockville Pike,
Rockville, MD. During the period required for relocation of the office,
which began on January 6, 1993, and ended on January 22, 1993, the
agency temporarily deferred submissions subject to CBER review and
approval, and the review period, if any, on pending submissions was
suspended. FDA also requested that sponsors voluntarily refrain from
filing submission during this period. Normal operations resumed on
January 25, 1993. FDA is also announcing the installation of automated
systems to make information available to the public and to help callers
identify the new telephone numbers of CBER staff involved in review
activities.
ADDRESSES: All submissions for CBER review should now be addressed to
the new location: Food and Drug Administration, Center for Biologics
Evaluation and Research, Document Control Center (HFM-99), Woodmont
Office Center, suite 200N, 1401 Rockville Pike, Rockville, MD 20852-
1448.
FOR FURTHER INFORMATION CONTACT: Mark A. Elengold, Center for Biologics
Evaluation and Research (HFM-11), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-594-2000.
SUPPLEMENTARY INFORMATION: CBER is responsible for many FDA activities
implementing the Federal Food, Drug, and Cosmetic Act, and section 351
of the Public Health Service Act (42 U.S.C. 262), including:
(1) Developing policy and procedures governing the premarket
approval, review, and evaluation of biological products;
(2) Receiving, reviewing, evaluating, and taking appropriate
action on investigational new drug applications (IND's) and
investigational device exemption applications (IDE's) for biological
products;
(3) Receiving, reviewing, evaluating, and taking appropriate
action on product license applications (PLA's) and establishment
license applications (ELA's) submitted for biological products;
(4) Receiving, reviewing, evaluating, and taking appropriate
action on new drug applications (NDA's), premarket approval
applications (PMA's), and premarket notifications (510k's) for which
CBER has been assigned responsibility; and
(5) Receiving, reviewing, evaluating, and taking appropriate
action on recommendations concerning denial, suspension, and revocation
of PLA's and ELA's.
In an effort to consolidate CBER offices, in January 1993, FDA
moved various CBER offices from locations in Bethesda, MD and
Rockville, MD to Woodmont Office Center, 1401 Rockville Pike,
Rockville, MD. During the move, CBER was unable to start or continue
work on new and existing submissions and reports. FDA temporarily
deferred action on the items listed above, and requested that sponsors
voluntarily refrain from filing submissions during this period, which
ended on January 22, 1993. All normal review operations resumed on
January 25, 1993.
All submissions for CBER review should now be addressed as
follows:
Food and Drug Administration, Center for Biologics Evaluation and
Research, Document Control Center (HFM-99), Woodmont Office Center,
suite 200N, 1401 Rockville Pike, Rockville, MD 20852-1448.
In addition, IND's, PLA's, ELA's, and amendments (supplements)
should be addressed to the application division within each office
having primary jurisdiction over the product, as follows: Office of
Blood Research and Review, Division of Blood Applications, (HFM-370),
301-594-2012; Office of Vaccine Research and Review, Division of
Vaccine and Related Products Applications (HFM-475), 301-594-2090;
Office of Therapeutics Research and Review, Division of Application
Review and Policy (HFM-585), 301-549-5656; and the Office of
Establishment Licensing and Product Surveillance, Division of
Establishment Licensing (HFM-205), 301-594-2049.
NOTE: Submissions for CBER Review Should No Longer Be Addressed to
the Director, CBER.
Additionally, to assist the public in obtaining information, FDA
has installed several automated systems. To obtain new telephone
numbers of CBER staff, or request copies of guidance documents, an
automated attendant device can be reached at 301-594-1800. The CBER FAX
Information System, 301-594-1939, can be called from a FAX machine with
a touch-tone telephone attached or built in. This system has current
CBER organizational listing and charts, as well as recent guidance
documents. Finally, CBER documents can be requested by sending Internet
mail to [email protected]. A list of documents available by
return Internet mail can be obtained by sending a message to
[email protected].
Dated: September 19, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-23617 Filed 9-22-94; 8:45 am]
BILLING CODE 4160-01-F