Guidance for Industry
 
 
Availability of FDAs eSubmitter 
Program for Regulatory Submissions 
from Licensed Blood Establishments
 
 
 
 
This guidance document is for immediate implementation. 
 
 
 
FDA is issuing this guidance for immediate implementation in accordance with  
21 CFR 10.115(g)(4)(i).  Submit written comments on this guidance at anytime to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852.  Submit electronic comments to http://www.regulations.gov.  You 
should identify all comments with the Docket No. FDA-2011-D-0579.   
 
Additional copies of this guidance are available from the Office of Communication, Outreach 
and Development (OCOD) (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, or by calling 1-800-835-4709 or 301-827-1800, or email ocod@fda.hhs.gov, or from the 
Internet at 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guida
nces/default.htm. 
 
For questions on the content of this guidance, contact OCOD at the phone numbers or email 
address listed above.  
 
               
  U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Biologics Evaluation and Research 
                                                                                                                                     August 2011                          Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
 
I.  INTRODUCTION.............................................................................................................1 
II.  BACKGROUND...............................................................................................................1 
III.  RECOMMENDATIONS..................................................................................................2 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
i  Contains Nonbinding Recommendations 
 
 
Guidance for Industry 
 
Availability of FDAs eSubmitter Program for Regulatory 
Submissions from Licensed Blood Establishments 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations.  If you want to discuss an alternative 
approach, contact the appropriate FDA staff.  If you cannot identify the appropriate FDA staff, 
call the appropriate number listed on the title page of this guidance. 
 
 
I.  INTRODUCTION 
 
We, FDA, the Center for Biologics Evaluation and Research (CBER), are announcing to you, 
licensed blood establishments that collect Whole Blood and blood components, including Source 
Plasma, the availability of CBERs eSubmitter Program (eSubmitter), an electronic submissions 
program.  The eSubmitter program is intended to facilitate submission and processing of 
regulatory filings, including biologics license applications (BLAs), BLA supplements (BLSs), 
annual reports and amendments to pending eSubmitter applications and supplements.  In this 
guidance, we describe how you may obtain and use the eSubmitter program. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, these guidances describe the FDAs current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory requirements 
are cited.  The use of the word should in FDAs guidances means that something is suggested or 
recommended, but not required. 
 
 
II.  BACKGROUND 
 
FDAs eSubmitter is an electronic submissions program that is available for voluntary use by 
sponsors, manufacturers, and importers to submit a variety of submission types for FDA-
regulated products.  The eSubmitter application software, which can be downloaded free of 
charge, assists applicants in the preparation of submissions that contain the minimum elements 
necessary for FDA to perform a comprehensive review.  
 
The eSubmitter program is designed to ensure that applicants include necessary information in 
their regulatory submissions.  The eSubmitter program also functions to guide users as they 
complete the filing process.  FDA believes that eSubmitter will help improve the consistency, 
quality and completeness of regulatory submissions and make the submission and review process 
more user-friendly for applicants.  In the future, additional instructions for electronic 
submissions may be posted on the FDA website.  
1  Contains Nonbinding Recommendations 
 
 
The FDA eSubmitter program is government-issued software governed by the Government 
Paperwork Elimination Act of 1998.  As a user of this software, you are not required to perform 
your own validation.  However, if you decide to use the software for purposes other than the 
intended uses identified in this guidance, you may be required to comply with additional 
requirements applicable to those intended uses.   
 
In the Federal Register of March 26, 2009, FDA announced an invitation to participate in a pilot 
evaluation program for the use of eSubmitter for BLAs and BLSs submitted by blood 
establishments that collect Source Plasma (74 FR 13210).  In the Federal Register of September 
7 2010, FDA announced an invitation to participate in another pilot evaluation program, this time 
for the use of eSubmitter for BLAs and BLSs submitted by blood establishments that collect 
Whole Blood and blood components (75 FR 54343).  These pilot programs were intended to 
provide industry and CBER regulatory staff the opportunity to evaluate the effectiveness of 
eSubmitter for these purposes.  FDA has completed its evaluation of these pilot programs and the 
agency now has decided to make this system broadly available.   
 
 
III.  RECOMMENDATIONS 
 
We have determined that eSubmitter is an acceptable mechanism for the submission of BLAs, 
BLSs, annual reports and amendments to pending eSubmitter regulatory submissions by licensed 
blood establishments that collect Whole Blood and blood components, including Source Plasma.  
The eSubmitter program is available to you at no charge from the FDAs website at 
http://www.fda.gov/ForIndustry/ FDAeSubmitter/default.htm.   
 
You may use the eSubmitter program for the submission of BLAs, BLSs, annual reports and 
amendments to pending eSubmitter regulatory submissions.  If you choose to prepare regulatory 
submissions using eSubmitter, you do not need to also submit a cover letter and/or paper copies 
of these submissions.   
 
Information entered into eSubmitter during preparation of regulatory submissions is currently 
required to be saved as a zip file onto a CD-ROM or DVD and mailed to CBER for review 
according to current managed review procedures.  
 
At this time, FDA will continue to accept paper regulatory submissions.  If you do not use 
eSubmitter for your submissions, you may still access eSubmitter to obtain and print a PDF file 
that contains the eSubmitter submission contents.   
 
Additional information for downloading, installing and using the eSubmitter program is available 
on FDAs website at http://www.fda.gov/ForIndustry/ FDAeSubmitter/default.htm.  
 
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