[Federal Register Volume 67, Number 86 (Friday, May 3, 2002)]
[Notices]
[Pages 22437-22438]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11062]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


An FDA/Industry Dialog on the Application Submission Process; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshops.

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    The Food and Drug Administration (FDA) is announcing two public 
workshops, both entitled ``An FDA/Industry Dialog on the Application 
Submission Process.'' The purpose of the public workshops is to discuss 
common application deficiencies and strategies to avoid these 
deficiencies leading to faster approval times. Staff from the Center 
for Biologics Evaluation and Research (CBER) will provide general 
information on the review process and options to consider. CBER staff 
also will lead discussion groups designed to respond to your general 
issues and questions on submission requirements. These discussion 
groups will be established based on the input provided to CBER on your 
issues relative to the purpose of this workshop.
    Date and Time: Send registration and issues by May 17, 2002, for 
the May 29, 2002, workshop and by June 14, 2002, for the June 26, 2002, 
workshop. See table 1 of this document.
    Location: See table 1 of this document.

                                                     Table 1
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           Meeting address                    Dates and local time                   FDA contact person
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Hyatt Regency Bethesda, 1 Bethesda    May 29, 2002, from 9 a.m. to 5 p.m.   Kathy Eberhart.
 Metro Center, Bethesda, MD 20814,
 301-657-1234.
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[[Page 22438]]

 
South San Francisco Conference        June 26, 2002, from 9 a.m. to 5 p.m.  Do.
 Center, 255 South Airport Blvd.,
 South San Francisco, CA 94080, 650-
 877-8787.
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Contact Persons:
    For information about this notice: Michael D. Anderson, Center for 
Biologics Evaluation and Research (CBER) (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6210, 
FAX 301-594-1944, e-mail: [email protected].
    For information about the workshop and registration: Kathy 
Eberhart, Center for Biologics Evaluation and Research (HFM-42), Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
827-2000, FAX 301-827-3079, e-mail [email protected].
    Procedure: Mail or fax your registration information (including 
name, professional degree, title, e-mail address, firm name, address, 
telephone, and fax number) to Kathy Eberhart, Center for Biologics 
Evaluation and Research (HFM-42), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-2000, FAX 301-827-3079, by 
May 17, 2002, for the May 29, 2002, workshop, and by June 14, 2002, for 
the June 26, 2002, workshop. There is no registration fee for the 
public workshops. Space is limited, therefore interested parties are 
encouraged to register early. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Kathy Eberhart (see Contact Persons) at least 7 days in 
advance.
    CBER is requesting that you submit your issues related to 
application deficiencies and approval times before the workshop. There 
will be an opportunity to submit additional issues and questions at the 
end of the morning sessions. Mail or fax your issues to Kathy Eberhart 
(see Contact Persons) by May 17, 2002, for the May 29, 2002, workshop 
and by June 14, 2002, for the June 26, 2002, workshop.

    Dated: April 26, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-11062 Filed 5-2-02; 8:45 am]
BILLING CODE 4160-01-S