[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25679-25680]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10025]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1160]


Center for Biologics Evaluation and Research eSubmitter Program 
for Electronic Submission of Postmarketing Adverse Event Reports for 
Human Vaccine Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency), Center for 
Biologics Evaluation and Research (CBER) is announcing the availability 
of a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program 
for the electronic submission of postmarketing individual case safety 
reports (ICSRs) and ICSR attachments of adverse events for human 
vaccine products (VAERS eSubmitter program). The VAERS eSubmitter 
program is a free software program for voluntary use that is intended 
to help persons subject to mandatory postmarketing requirements for 
vaccines including applicants, manufacturers, packagers, and 
distributors to electronically submit ICSRs and ICSR attachments as 
required by the final rule titled ``Postmarketing Safety Reports for 
Human Drug and Biological Products; Electronic Submission 
Requirements.'' The VAERS eSubmitter program creates a simple and 
efficient mechanism for the secure electronic submission of 
postmarketing ICSRs and ICSR attachments into the VAERS database 
without the need for an internal database that is compatible with the 
International Conference on Harmonisation (ICH)-based direct database 
to database submission system.

FOR FURTHER INFORMATION CONTACT: Bioinformatics Support Staff, Office 
of Review Management, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of the VAERS eSubmitter program 
for the electronic submissions of postmarketing ICSRs and ICSR 
attachments of adverse events for human vaccine products. The VAERS 
eSubmitter program is available for voluntary use by applicants and 
others required to report postmarketing adverse events, as described 
above, to submit an initial or follow-up ICSR document for human 
vaccine products. The eSubmitter application software, which can be 
downloaded free of charge, assists users in the preparation of 
submissions that contain the minimum elements necessary for FDA to 
perform a comprehensive review.
    The eSubmitter ICSR template for vaccines is designed to ensure 
that those submitting postmarketing ICSRs and ICSR attachments include 
necessary information in these regulatory submissions. It is also 
designed to guide users of the system as they complete the ICSR file 
creation and submission process. The VAERS eSubmitter program will help 
to improve the consistency, quality, and completeness of ICSR 
submissions and make the submission and review process more user-
friendly for those required to report postmarketing adverse events for 
human vaccine products.
    FDA published in the Federal Register of June 10, 2014 (79 FR 
33072), a final rule titled ``Postmarketing Safety Reports for Human 
Drug and Biological Products; Electronic Submission Requirements,'' 
which requires, in part, that applicants and other adverse event 
reporters submit postmarketing ICSRs and ICSR attachments to CBER in an 
electronic format that the Agency can process, review, and archive. The 
final rule became effective June 10, 2015. Postmarketing ICSRs and ICSR 
attachments sent to CBER for human vaccines are processed into the 
VAERS database. As discussed in the preamble to the final rule and in 
CBER's final guidance for industry ``Providing Submissions in 
Electronic Format--Postmarketing Safety Reports for Vaccines,'' dated 
August 2015 (August 2015 Guidance), FDA is providing two voluntary 
options for electronic submission of ICSRs and ICSR attachments into 
VAERS: (1) Direct database to database submission through the 
Electronic Submissions Gateway (ESG), and (2) submission of safety 
reports through the VAERS eSubmitter program as described on the CBER 
eSubmitter Web page (available at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm191387.htm). Applicants and others required to report

[[Page 25680]]

postmarketing adverse events can choose either option to electronically 
submit ICSRs and ICSR attachments to VAERS.
    The ICSR eSubmitter software is a government-issued software 
provided in support of the Government Paperwork Elimination Act of 1998 
(44 U.S.C. 3504). As users of the eSubmitter software, applicants and 
others required to report postmarketing adverse events are not required 
to perform their own file validation process. The purpose of the ICSR 
eSubmitter template is to facilitate the electronic submission of 
postmarketing vaccine safety reports using internationally adopted data 
standards to enhance regulatory review, exchange and dissemination of 
vaccine safety information. Applicants and others who choose to use the 
eSubmitter program for required postmarketing reporting of adverse 
events for human vaccine products must first download the eSubmitter 
software and then manually enter information into the ICSR template 
form to create each electronic ICSR or ICSR attachment for submission 
to FDA through the ESG for uploading to the VAERS database. Further 
information on submitting ICSRs and ICSR attachments using eSubmitter 
is included in the August 2015 Guidance (available at: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/default.htm), and on the CBER eSubmitter Web page referenced above.

    Dated: April 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10025 Filed 4-28-16; 8:45 am]
 BILLING CODE 4164-01-P