[Federal Register Volume 79, Number 35 (Friday, February 21, 2014)]
[Notices]
[Pages 9908-9909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03677]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0720]
International Conference on Harmonisation; E2B(R3) Electronic
Transmission of Individual Case Safety Reports; Data Elements and
Message Specification; Appendix on Backwards and Forwards
Compatibility; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing 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) and an appendix to the guidance entitled
``ICSRs: Appendix to the Implementation Guide--Backwards and Forwards
Compatibility'' (the BFC appendix). The guidance was prepared under the
auspices of the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH).
The E2B(R3) implementation guidance is intended to revise the standards
for submission of ICSRs and improve the inherent quality of the data,
enabling improved handling and analysis of ICSR reports. The BFC
appendix describes the relationship between data elements from the 2001
ICH E2B guidance and the E2B(R3) implementation guidance.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information (HFD-240), Center for Drug Evaluation
and Research (CDER), Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or the Office
of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist the office in processing your
requests. The guidance may also be obtained by mail by calling CBER at
1-800-835-4709 or 301-827-1800. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Roger Goetsch,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg 22, Rm. 4491, Silver Spring, MD 20993-
0002, 240-402-3730; or Lise Stevens, Center for Biologics Evaluation
and Research (HFM-17), Food and Drug Administration, 1401 Rockville
Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-2743, Regarding the
ICH: Michelle Limoli, Center for Drug Evaluation and Research,
International Programs, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3342, Rockville, MD 20993-0002, 301-796-
8377.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA;
and the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the
[[Page 9909]]
preparation of documentation, is provided by the International
Federation of Pharmaceutical Manufacturers Associations (IFPMA).
The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
In the Federal Register of October 20, 2011 (76 FR 65199), FDA
published a notice announcing the availability of a draft guidance
entitled ``E2B(R3) Electronic Transmission of Individual Case Safety
Reports (ICSRs): Implementation Guide--Data Elements and Message
Specification'' and an appendix to the guidance entitled ``ICSRs:
Appendix to the Implementation Guide--Backwards and Forwards
Compatibility.'' FDA also published a correction notice (November 16,
2011, 76 FR 71044) giving interested persons an opportunity to submit
comments by January 18, 2012.
After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in November 2012.
The guidance provides guidance on the data elements, terminology,
and exchange standards for the submission of ICSRs to improve the
inherent quality of adverse event data and enable improved handling and
analysis of ICSRs. The E2B(R3) implementation guidance provides support
for the implementation of software tools for creating, editing,
sending, and receiving electronic ICSR messages. The E2B(R3)
implementation guidance also provides instruction for how
pharmaceutical industries and regulatory authorities should use the
``International Organization for Standardization (ISO) 27953-2 (Part
2)'' ICSR messaging standard for exchanging pharmacovigilance
information among ICH regions and in other countries adopting ICH
guidelines. The BFC appendix describes the relationship between data
elements from E2B(R2) and E2B(R3) and is intended to assist reporters
and recipients in implementing systems with special focus on the
recommendations for converting back and forth between E2B(R2) and
E2B(R3) ICSR reports. The E2B(R3) implementation guidance and BFC
appendix are being issued as a package that includes schema files and
additional technical information to be used for creating compliant ICSR
files.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's 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. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Dated: February 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03677 Filed 2-20-14; 8:45 am]
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