[Federal Register Volume 69, Number 24 (Thursday, February 5, 2004)]
[Notices]
[Pages 5551-5552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2314]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1996D-0041]


International Conference on Harmonisation; Guidance on Addendum 
to E2C Clinical Safety Data Management: Periodic Safety Update Reports 
for Marketed Drugs; 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 entitled ``Addendum to E2C Clinical Safety 
Data Management: Periodic Safety Update Reports for Marketed Drugs'' 
(the ICH E2C guidance). The guidance was prepared under the auspices of 
the International Conference on Harmonisation of Technical Requirements 
for Registration of Pharmaceuticals for Human Use (ICH). In the Federal 
Register of May 19, 1997 (62 FR 27470), FDA published the ICH E2C 
guidance, which recommends a unified standard for the format, content, 
and reporting frequency for postmarketing periodic safety update 
reports (PSURs) for drug and biological products. This guidance, an 
addendum to the ICH E2C guidance, provides additional information on 
the content and format of PSURs, including clarification of the 
objectives, general principles, and model for PSURs. This guidance is 
intended to help harmonize collection and submission of postmarketing 
clinical safety data.

DATES: You may submit written or electronic comments at any time.

ADDRESSES: Submit written comments on the 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 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, 301-827-
3844, FAX: 888-CBERFAX. Send two self-addressed adhesive labels to 
assist the office in processing your requests. Requests and comments 
should be identified with the docket number found in brackets in the 
heading of this document. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Min Chen, Center for Drug Evaluation and 
Research (HFD-430), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3159, or Miles Braun, Center for Biologics 
Evaluation and Research (HFM-220), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852, 301-827-6090.
    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 
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

[[Page 5552]]

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 December 31, 2002 (67 FR 79939), FDA 
published a notice announcing the availability of a draft tripartite 
guidance entitled ``Addendum to E2C Clinical Safety Data Management: 
Periodic Safety Update Reports for Marketed Drugs.'' The notice gave 
interested persons an opportunity to submit comments by January 24, 
2003.
    After consideration of the comments received and revisions to the 
draft guidance, a final draft of the guidance was submitted to the ICH 
steering committee and endorsed by the three participating regulatory 
agencies in February 2003.
    This guidance provides additional information on the objectives, 
general principles, and model for PSURs specified in the ICH E2C 
guidance, including clarification of the following topics:
     When separate PSURs will be considered 
appropriate,
     Synchronization of National Birthdates with the 
International Birthdates,
     Reporting frequency and time for submission 
changes, and
     Use of the reference safety information.
    In addition, this guidance includes information on the following 
topics not previously addressed in the ICH E2C guidance.
     Summary bridging reports and addendum reports,
     Executive summaries, and
     Information on risk management programs and 
risk-benefit analyses.
    The document should be used in conjunction with the ICH E2C 
guidance.
    This 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, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written comments on the guidance. 
Two copies of any comments are to be submitted, except that individuals 
may submit one copy. Comments are to be identified with the docket 
number found in brackets in the heading of this document. The 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: January 23, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-2314 Filed 2-4-04; 8:45 am]
BILLING CODE 4160-01-S