[Federal Register Volume 74, Number 57 (Thursday, March 26, 2009)]
[Notices]
[Pages 13210-13211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6687]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0134]


Center for Biologics Evaluation and Research eSubmitter Pilot 
Evaluation Program for Source Plasma Establishments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration's (FDA's) Center for 
Biologics Evaluation and Research (CBER) is announcing an invitation to 
participate in a pilot evaluation program for CBER's eSubmitter Program 
(eSubmitter). CBER's eSubmitter has been customized as an automated 
biologics license application (BLA) and BLA supplement (BLS) submission 
system for blood and blood components. Participation in the pilot 
program is open to blood establishments that collect Source Plasma. The 
pilot program is intended to provide industry and CBER regulatory 
review staff the opportunity to evaluate the eSubmitter system and 
determine if it facilitates the BLA/BLS submission process. The purpose 
of this notice is to invite blood establishments that collect Source 
Plasma to submit a request to CBER if they are interested in 
participating in this pilot program.

[[Page 13211]]


DATES:  Submit a written or electronic request for participation in 
this program by April 27, 2009. You should include the following 
information in your request: contact name, contact phone number, e-mail 
address, name of the establishment, address, and license number (if 
applicable).

ADDRESSES:  If you are interested in participating in this program, you 
should submit a request to participate in the program to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic requests 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Lore Fields, Center for Biologics 
Evaluation and Research (HFM-375), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6143, 
Fax: 301-827-3534, or e-mail: <a href="/cdn-cgi/l/email-protection#dab6b5a8bff4bcb3bfb6bea99abcbebbf4b2b2a9f4bdb5ac"><span class="__cf_email__" data-cfemail="076b68756229616e626b637447616366296f6f7429606871">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates certain biological products, including blood and 
blood products, and is committed to advancing the public health through 
innovative activities that help ensure the safety, effectiveness and 
timely delivery of these products to patients. Further, CBER seeks to 
continuously enhance and update review efficiency and quality, and the 
quality of its regulatory efforts and interactions, by providing CBER 
staff and industry with improved processes. In support of this goal, 
CBER has participated in the FDA development of a computer-assisted 
automated BLA/BLS submission program called eSubmitter to improve the 
process for providing certain regulatory submissions to FDA. The 
eSubmitter will include programs to submit applications for licensure, 
supplements to an approved license, and amendments to pending 
applications or supplements.

II. The eSubmitter Pilot Evaluation Program Expectations

    The eSubmitter pilot evaluation program is expected to last 
approximately 6 months. During this period of time, participants will 
complete BLA/BLS regulatory submissions using the eSubmitter template 
developed at CBER for use by Source Plasma establishments. The 
eSubmitter was developed using the same review criteria for 
applications for these products as currently used in the BLA/BLS review 
process at CBER. During the BLA/BLS submission process, the 
participants will enter the requested information into the eSubmitter 
tool and attach requested documents as an Adobe document (pdf format). 
This information will be saved onto a CD-ROM and mailed to CBER for 
review. Paper copies of submissions will not be required. CBER will 
review the information provided on the CD-ROM and the attachments 
according to current managed review procedures.
    During the BLA/BLS submission process, CBER staff will be available 
to answer any questions or concerns that may arise. As each submission 
is completed, the users will be asked to comment on the eSubmitter 
program. These discussions will assist CBER in the final development 
and release of this electronic tool for use by industry.

III. Requests for Participation

    Requests to participate in the eSubmitter pilot are to be 
identified with the docket number found in brackets in the heading of 
this document. Once requests for participation are received, FDA will 
contact interested establishments to discuss the pilot program.

    Dated: March 20, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-6687 Filed 3-25-09; 8:45 am]
BILLING CODE 4160-01-S


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>