[Federal Register Volume 70, Number 190 (Monday, October 3, 2005)]
[Notices]
[Pages 57610-57611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0390]


International Conference on Harmonisation; Draft Guidance on 
E2B(R) Clinical Safety Data Management: Data Elements for Transmission 
of Individual Case Safety Reports; 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availability of a draft guidance entitled ``E2B(R) Clinical Safety Data 
Management: Data Elements for Transmission of Individual Case Safety 
Reports.'' The draft guidance was prepared under the auspices of the 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use (ICH). The draft 
guidance, which revises previous guidance on the same topic, provides 
standardized data elements for the transmission of individual case 
safety reports for preapproval and postapproval reporting periods. The 
revisions in this draft guidance include additional information and 
clarifications for the electronic transmission of individual case 
safety reports. The draft guidance is intended to be used with other 
ICH recommendations for electronic transmissions.

DATES: Submit written or electronic comments on the draft guidance by 
October 28, 2005. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written comments on the draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. Submit written 
requests for single copies of the draft guidance to the Division of 
Drug Information (HFD-240), Center for Drug Evaluation and Research, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857; 
or the Office of Communication, Training and Manufacturers Assistance 
(HFM-40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The 
draft guidance may also be obtained by mail by calling the Center for 
Biologics Evaluation and Research (CBER) Voice Information System at 1-
800-835-4709 or 301-827-1800. Send two self-addressed adhesive labels 
to assist the office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Roger Goetsch, Center for Drug Evaluation 
and Research (HFD-410), Food and Drug Administration, 12300 Twinbrook 
Pkwy., Rockville, MD 20851, 301-770-9299, or Lise Stevens-Hawkins, 
Center for Biologics Evaluation and Research (HFM-220), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6085.
    Regarding the ICH: Michelle Limoli, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4480.

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

[[Page 57611]]

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; 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.
    The ICH guidance entitled ``E2B Data Elements for Transmission of 
Individual Case Safety Reports'' was signed off by ICH in July 1997 and 
issued by FDA in January 1998 (63 FR 2396, January 15, 1998). ICH 
subsequently issued a revised guidance entitled ``E2B(M) Clinical 
Safety Data Management: Data Elements for Transmission of Individual 
Case Safety Reports'' (E2B(M)), to provide additional information and 
clarification. ICH signed off on E2B(M) in November 2001, and FDA 
issued the revised guidance in April 2002.
    In May 2005, the ICH Steering Committee agreed that the E2B(M) 
draft guidance should be made available for public comment. The draft 
guidance is the product of the E2B(R) Expert Working Group of the ICH. 
Comments about the draft guidance will be considered by FDA and the 
E2B(R) Expert Working Group.
    FDA is announcing the availability of the draft guidance entitled 
``E2B(R) Clinical Safety Data Management: Data Elements for 
Transmission of Individual Case Safety Reports,'' which revises the 
previous E2B guidances to include additional information and 
clarification for the electronic transmission of individual case safety 
reports. The draft guidance incorporates adjustments based on 
experience gained after implementation of the guidance in the three ICH 
regions and expands the use of the standard data elements to support 
vaccine reporting. For electronic transmissions, the draft guidance is 
intended to be used with the ICH M2 individual case safety report 
(ICSR) message specification. The draft guidance recommends that 
electronic transmission of individual case safety reports be 
implemented using the Medical Dictionary for Regulatory Activities 
(MedDRA) and ICH M5 data elements and standards where applicable.
    FDA has identified in public Docket No. 1992S-0251 (formerly Docket 
No. 92S-0251) postmarketing individual case safety reports as 
submission types that the agency can accept in electronic format. FDA 
believes the ICH recommendations for the electronic transmission of 
these reports will result in more effective and efficient safety 
reporting to regulatory authorities worldwide.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance and 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 document at 
http://www.fda.gov/ohrms/dockets/default.htm, http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/publications.htm.

    Dated: September 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19655 Filed 9-30-05; 8:45 am]
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