[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]
BILLING CODE 4160-01-P