[Federal Register Volume 75, Number 172 (Tuesday, September 7, 2010)]
[Pages 54343-54344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22167]



Food and Drug Administration

[Docket No. FDA-2010-N-0436]

Center for Biologics Evaluation and Research eSubmitter Pilot 
Evaluation Program for Blood Establishments That Collect Whole Blood 
and Blood Components

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY: The Food and Drug Administration (FDA), 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 Whole Blood and 
blood components. 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 Whole Blood and blood components to submit a request to CBER if 
they are interested in participating in this pilot program.

DATES: Submit a written or electronic request for participation in this 
program by October 7, 2010.

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, email: [email protected].


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. eSubmitter 
will include programs to submit applications for licensure, supplements 
to an approved license, and amendments to pending applications or 

II. The eSubmitter Pilot Evaluation Program Expectations

    The eSubmitter pilot evaluation program is expected to last 
approximately 12 months. During this period of time, participants will 
complete BLA/BLS regulatory submissions using the eSubmitter template 
developed at CBER for use by blood establishments that collect Whole 
Blood and blood components. 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. You should include the following information in your 
request: Contact name, contact phone number, email address, name of the 
establishment, address, and license number. Once requests for 
participation are received, FDA will contact interested establishments 
to discuss the pilot program.

[[Page 54344]]

    Dated: August 31, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-22167 Filed 9-3-10; 8:45 am]