[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]
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