[Federal Register Volume 76, Number 203 (Thursday, October 20, 2011)]
[Notices]
[Pages 65199-65200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27147]


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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Transmission of Individual Case Safety Reports; Draft Guidance on 
Implementation; 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availability of a draft guidance entitled ``E2B(R3) Electronic 
Transmission of Individual Case Safety Reports (ICSRs): Implementation 
Guide--Data Elements and Message Specification'' (the draft E2B(R3) 
implementation guidance) and an appendix to the draft guidance entitled 
``ICSRs: Appendix to the Implementation Guide--Backwards and Forwards 
Compatibility'' (the draft BFC appendix). The draft E2B(R3) 
implementation guidance and draft BFC appendix were prepared under the 
auspices of the International Conference on Harmonisation of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH). 
The draft 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 
draft BFC appendix describes the relationship between data elements 
from the 2001 ICH E2B guidance and draft E2B(R3) implementation 
guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on 
these draft documents before it begins work on the final versions of 
the documents, submit either electronic or written comments on the 
draft documents by January 18, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
documents to the Division of Drug Information (HFD-240), Center for 
Drug Evaluation and Research, 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, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist the office in processing your 
requests. The draft documents 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 draft documents.
    Submit electronic comments on the draft documents 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:

Krishna K. Chary, Center for Drug Evaluation and Research, Food and 
Drug Administration, 8201 Corporate Dr., suite 540, Landover, MD 20785, 
240-487-7377, fax: 301-459-2285, e-mail: [email protected]; or
Deborah F. Yaplee, Center for Biologics Evaluation and Research (HFM-
25), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-3288, fax: 301-827-9434, e-mail: 
[email protected].

    Regarding the ICH:

Michelle Limoli, Office of International Programs, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 3506, Silver 
Spring, MD 20993, 301-796-4600.

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.
    The 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, Labor, and Welfare; the 
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug 
Evaluation and Research and Biologics Evaluation and Research, FDA; and 
the Pharmaceutical Research and Manufacturers of America. The ICH 
Secretariat, which coordinates the 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 June and July 2011, the ICH Steering Committee agreed that a 
draft guidance entitled ``E2B(R3) Electronic Transmission of Individual 
Case Safety Reports (ICSRs): Implementation Guide--Data Elements and 
Message Specification'' and a draft appendix entitled ``ICSRs: Appendix 
to the Implementation Guide--Backwards and Forwards Compatibility'' 
should be made available for public comment. The documents are the 
product of the E2B(R3) Expert Working Group of the ICH. Comments about 
these documents will be considered by FDA and the E2B(R3) Expert 
Working Group.
    The key intention of the draft E2B(R3) implementation guidance is 
to revise the standards for submission of ICSRs and improve the 
inherent quality of the data, enabling improved handling and analysis 
of ICSRs. The draft E2B(R3) implementation guidance provides support 
for the implementation of software tools for creating, editing, 
sending, and receiving electronic ICSR messages. The draft E2B(R3) 
implementation guidance provides instruction for how pharmaceutical 
industries and regulatory authorities should use Part 2 of the 
International Organization for Standardization (ISO) ICSR standard to 
construct messages for exchanging pharmacovigilance information among 
themselves in ICH regions, and in other countries adopting ICH 
guidelines. The draft BFC appendix describes the relationship between 
data

[[Page 65200]]

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 draft E2B(R3) implementation guidance and 
draft BFC appendix are being issued as a package that includes schema 
files and additional technical information.
    The draft E2B(R3) implementation guidance and BFC appendix are 
being issued consistent with FDA's good guidance practices regulation 
(21 CFR 10.115). The documents, when finalized, will represent the 
Agency's current thinking on this topic. The documents do not create or 
confer any rights for or on any person and do 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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding these 
documents. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

III. Electronic Access

    Persons with access to the Internet may obtain the documents 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: October 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27147 Filed 10-19-11; 8:45 am]
BILLING CODE 4160-01-P