[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International Conference on Harmonisation; Draft Guidance on E2D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availability of a draft guidance entitled ``E2D Postapproval Safety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The draft guidance was prepared under the auspices of the International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 The draft guidance provides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 The draft guidance is intended to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DATES: Submit written or electronic comments on the draft guidance by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Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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access to the draft guidance document.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draft guidance to the Division of Dockets Management (HFA-305), Food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