[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Pages 20924-20925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08012]



Food and Drug Administration

[Docket No. FDA-2013-N-0248]

Center for Biologics Evaluation and Research eSubmitter Pilot 
Evaluation Program for Investigational New Drug Applications

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 
sponsors of investigational new drug (IND) applications to participate 
in a pilot evaluation program for CBER's eSubmitter Program 
(eSubmitter). CBER's eSubmitter is a computer-assisted automated 
program that has been customized to facilitate the creation of IND 
applications in electronic format, including a template specifically 
for IND applications related to antivenom drugs/antivenins. 
Participation in the pilot program is open to sponsors that submit IND 
applications to the Office of Blood Research and Review, the Office of 
Cellular, Tissue and Gene Therapy, or the Office of Vaccines Research 
and Review in CBER. CBER will only accept participation from up to nine 
sponsors. The pilot program is intended to provide industry and CBER 
regulatory review staff with an opportunity to evaluate the eSubmitter 
system and determine if it facilitates the IND submission process. The 
purpose of this notice is to invite sponsors of IND applications to 
contact CBER for more information if they are interested in 
participating in this pilot program.

DATES: Submit an electronic request for participation in this program 
by July 8, 2013.

ADDRESSES: If you are interested in participating in this program, you 
should submit an electronic request to [email protected].

FOR FURTHER INFORMATION CONTACT: Lore Fields, Office of Blood Research 
and Review, 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 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 the 
efficiency and quality of its regulatory review process and to 
facilitate its interaction with stakeholders by providing CBER staff 
and industry with improved processes. In support of this goal, CBER has 
participated in FDA's development of eSubmitter to improve the process 
for providing certain regulatory submissions to FDA.

II. 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 their IND application submissions using the eSubmitter 
template developed by FDA that has been specifically designed for use 
by IND sponsors. eSubmitter was developed using the same criteria for 
applications that are currently used in the IND application review 
process at CBER. To create the IND application, the participant 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 by the sponsor and mailed to CBER for 
review. Paper copies of submissions will not be required. CBER will 
review the information provided on

[[Page 20925]]

the CD-ROM and the attachments according to current managed review 
procedures. Only new IND applications and their amendments will be 
eligible for participation in the pilot program.
    During the IND application process, CBER staff will be available to 
answer any questions or concerns that may arise. As each application is 
completed, the users will be asked to comment on the eSubmitter 
program. These comments and discussions will assist CBER in the final 
development and release of this electronic program for use by industry.

III. Requests for Participation

    Requests to participate in the eSubmitter Pilot Evaluation Program 
should be sent electronically to [email protected]. 
You should include the following information in your request: Contact 
name, contact phone number, email address, name of the facility, 
address, and registration number (if applicable). Once requests for 
participation are received, FDA will contact interested sponsors to 
discuss the pilot program.

    Dated: April 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-08012 Filed 4-5-13; 8:45 am]