Document ID: FDA-2014-N-0604-0001
Agency: fda
Document Type: Notice
Title: Electronic Submission of Postmarketing Safety Reports
Involving Vaccine Products; Notice of Pilot Project
Posted Date: 2014-05-28T04:00Z

[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30620-30621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12291]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0604]

Electronic Submission of Postmarketing Safety Reports Involving 
Vaccine Products; Notice of Pilot Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Biologics Evaluation and Research (CBER) in the 
Food and Drug Administration (FDA) is announcing a pilot project to 
evaluate its current systems for receiving postmarketing safety reports 
involving vaccine products electronically for processing into the 
Vaccine Adverse Event Reporting System (VAERS). As part of this pilot 
project, CBER also plans to assess the updated International Conference 
on Harmonization of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH) E2B(R3) specification for 
electronic transmission of vaccine Individual Case Safety Reports 
(ICSRs). Participation in the pilot project is open to firms that 
submit postmarketing reports into VAERS. CBER plans to accept 
participation from up to six applicants. The pilot project is intended 
to provide industry and CBER regulatory review staff with an 
opportunity to evaluate current system capabilities for sending and 
receiving postmarketing safety reports for vaccine products using FDA's 
Electronic Submissions Gateway (ESG), including the use of the updated 
ICH E2B(R3) specification.

DATES: Submit an electronic request to participate in this pilot 
project by June 27, 2014.

ADDRESSES: If you are interested in participating in this pilot 
project, you should submit an electronic request to eSubmitter_program@fda.hhs.gov">CBER_eSubmitter_program@fda.hhs.gov.

[[Page 30621]]

FOR FURTHER INFORMATION CONTACT: Lise Stevens, Food and Drug 
Administration, Center for Biologics Evaluation and Research, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 7323, Silver Spring, MD 20993-0002, 240-
402-8169, email: lise.stevens@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    CBER regulates certain biological products, including vaccines, 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. This includes improving the 
processes for providing certain regulatory submissions to FDA.
    CBER is announcing a pilot project to evaluate its current systems 
for receiving postmarketing safety reports involving vaccine products 
electronically for processing into VAERS. VAERS is a cooperative 
program for vaccine safety of the FDA and the Centers for Disease 
Control and Prevention. VAERS collects postmarketing surveillance 
information about adverse events (unlabeled, serious events) that occur 
after the administration of U.S. licensed vaccines. This includes the 
collection of ICSRs that report on adverse experiences related to an 
individual patient or subject.
    As part of this pilot project, CBER also wishes to assess the 
updated ICH E2B(R3) specification for electronic transmission of 
vaccine ICSRs. The ICH E2B(R3) specification addresses the electronic 
submission of ICSRs and is intended to improve the inherent quality of 
the data, enabling improved handling and analysis of ICSR reports.
    In the Federal Register of February 21, 2014 (79 FR 9908), FDA 
announced the availability of a guidance for industry entitled 
``E2B(R3) Electronic Transmission of Individual Case Safety Reports 
(ICSRs): Implementation Guide--Data Elements and Message 
Specification'' (the E2B(R3) implementation guidance), as well as an 
appendix to the guidance entitled ``ICSRs Appendix to the 
Implementation Guide--Backwards and Forwards Compatibility.'' The 
E2B(R3) implementation guidance provides recommendations on the data 
elements, terminology, and exchange standards for the electronic 
submission of ICSRs. The E2B(R3) implementation guidance also provides 
information for the development of software tools for creating, 
editing, sending, and receiving electronic ICSR messages. The E2B(R3) 
implementation guidance is available on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

II. Pilot Project Participation

    The pilot project to evaluate FDA's current systems for receiving 
postmarketing safety reports involving vaccine products electronically 
into VAERS, as well as to assess the updated ICH E2B(R3) specification, 
is to last for approximately 3 months, but it may be extended as 
needed. During the pilot, CBER staff will be available to answer any 
questions or concerns that may arise. Pilot project participants will 
be asked to comment on their experience in the pilot. These comments 
and discussions will assist CBER in its development of this electronic 
program.

III. Requests for Participation

    Requests to participate in the pilot project should be sent 
electronically to eSubmitter_program@fda.hhs.gov">CBER_eSubmitter_program@fda.hhs.gov. You should 
include the following information in your request: Contact name, 
contact phone number, and contact email address. Once requests for 
participation are received, FDA will contact interested applicants to 
discuss the pilot project. FDA is seeking a limited number of 
participants (no more than six) to participate in this pilot project. 
The pilot project is expect to last approximately 3 months but may be 
extended as needed.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12291 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P