[Federal Register: September 15, 2003 (Volume 68, Number 178)]
[Notices]               
[Page 53983-53984]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se03-85]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0412]

 
International Conference on Harmonisation; Draft Guidance on E2D 
Postapproval Safety Data Management: Definitions and Standards for 
Expedited Reporting; 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availability of a draft guidance entitled ``E2D Postapproval Safety 
Data Management: Definitions and Standards for Expedited Reporting.'' 
The draft guidance was prepared under the auspices of the International 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 The draft guidance provides 
definitions associated with postapproval product safety information and 
standards for collecting and expedited reporting of safety information 
to the regulatory authorities. The draft guidance is intended to 
harmonize internationally the collection and management of postapproval 
product safety data.

DATES: Submit written or electronic comments on the draft guidance by 
October 20, 2003.

ADDRESSES: Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 (CBER), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-3844, FAX: 888-CBERFAX. 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access to the draft guidance document. 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draft guidance to the Division of Dockets Management (HFA-305), Food 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.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Susan Lu, Center for Drug Evaluation and 
Research (HFD-430), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1514; or Tim Cote, Center for Biologics 
Evaluation and Research (HFM-224), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-6088.
    Regarding the ICH: Janet Showalter, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0865.

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; 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's Health Products and Food Branch, 
and the European Free Trade Area.
    In July 2003, the ICH Steering Committee agreed that a draft 
guidance entitled ``E2D Postapproval Safety Data Management: 
Definitions and Standards for Expedited Reporting'' should be made 
available for public comment. The draft guidance is the product of the 
Efficacy Expert Working Group of the ICH. Comments about this draft 
guidance will be considered by FDA and the Efficacy Expert Working 
Group.
    In the Federal Register of March 1, 1995 (60 FR 11284), FDA 
published the ICH guidance entitled ``E2A Clinical Safety Data 
Management: Definitions and Standards for Expedited Reporting,'' which 
provides guidance on preapproval safety data management. This ICH E2D 
draft guidance is based on the content of ICH E2A and provides further 
guidance on definitions associated with postapproval product safety 
information and standards for collecting and expedited reporting of 
safety information to the regulatory authorities.
    This 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. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be

[[Page 53984]]

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/publications.htm.

    Dated: September 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-23508 Filed 9-12-03; 8:45 am]

BILLING CODE 4160-01-S