[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