[Federal Register Volume 65, Number 121 (Thursday, June 22, 2000)]
[Notices]
[Pages 38835-38836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Temporary Deferment of Activities Relating to Certain Biologics 
Submissions

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 converting 
its current biologics license application (BLA) data base system into a 
new data base system. During the period required for this conversion, 
the agency will temporarily defer certain submissions subject to CBER 
review and approval, and the review period, if any, on pending 
submissions will be suspended. FDA plans to temporarily defer action on 
submissions related to BLA's, product license applications (PLA's), 
establishment license applications (ELA's), and any related 
correspondence. FDA is also requesting that sponsors voluntarily 
refrain from filing the affected submissions during this period. FDA 
estimates that the deferment period will be about 1 month.

FOR FURTHER INFORMATION CONTACT: Robert A. Yetter, Center for Biologics 
Evaluation and Research (HFM-10), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-2000.

SUPPLEMENTARY INFORMATION: 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

[[Page 38836]]

receiving, reviewing, evaluating, and taking appropriate action on a 
variety of submissions concerning various regulated products, 
including: (1) Investigational new drug applications (IND's) and 
investigational device exemption applications (IDE's) for certain 
products for which CBER has been assigned responsibility; (2) BLA's, 
PLA's, and ELA's submitted for biological products; and (3) new drug 
applications (NDA's), premarket approval applications (PMA's), and 
premarket notifications (510k's) for which CBER has been assigned 
responsibility.
    In an effort to upgrade CBER's data base and tracking system for 
license applications, CBER is converting to a new data base system 
starting in June 2000. Because of this conversion, CBER will be unable 
to start work or continue work on certain pending submissions and 
reports until conversion to the new system is ready; therefore, FDA 
plans to temporarily defer action on certain submissions subject to 
CBER review and approval, including BLA's, PLA's, ELA's, and related 
correspondence. Other submissions subject to CBER review and approval, 
including IND's, NDA's, 510k's, PMA's, or IDE's will not be affected by 
the conversion and temporary deferment. FDA is requesting that 
applicants voluntarily refrain from filing the affected submissions 
during the conversion period, which will begin on June 26, 2000, and is 
expected to continue until July 20, 2000. CBER will try to complete the 
conversion and begin processing submissions sooner than the specified 
timeframe. Confirmation of the resumption of normal review procedures 
and any change in this timeframe will be announced on the Internet on 
CBER's home page at http://www.fda.gov/cber/genadmin.htm.
    FDA anticipates that this period will be about 1 month or less. 
Although FDA will continue to accept mail during this period, affected 
submissions and related correspondence will neither be officially 
logged in nor will review of affected submissions or related 
correspondence begin. Any review period will not begin until the 
conversion is completed and CBER review functions resume. CBER will 
attempt to keep the mail in the order of the day received. When work 
resumes, the mail will be handled in the order in which it was 
received. Also, the review periods on pending submissions will be 
suspended during the conversion period. The action due date for all 
pending submissions will be extended by the length of the actual 
deferment. CBER will attempt to minimize the period during which 
regular procedures are suspended.
    Persons who may be affected by this temporary deferment should call 
the contact person listed above or CBER's Office of Communication, 
Training, and Manufacturer's Assistance at 301-827-2000 with any 
questions regarding the conversion.

    Dated: June 14, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-15554 Filed 6-21-00; 8:45 am]
BILLING CODE 4160-01-F