[Federal Register Volume 69, Number 61 (Tuesday, March 30, 2004)]
[Notices]
[Pages 16579-16580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0117]


International Conference on Harmonisation; Draft Guidance on E2E 
Pharmacovigilance Planning; 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availability of a draft guidance entitled ``E2E Pharmacovigilance 
Planning.'' The draft guidance was prepared under the auspices of the 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 The draft guidance 
describes a method for summarizing the identified risks of a drug, the 
potential for important unidentified risks, and the potentially at-risk 
populations and situations that were not studied before the drug was 
approved. The draft guidance is intended to foster better and earlier 
planning of pharmacovigilance activities, especially in preparation for 
the early postmarketing period of a new drug.

DATES: Submit written or electronic comments on the draft guidance by 
May 19, 2004.

ADDRESSES: Submit written comments on the draft guidance to the 
Division of

[[Page 16580]]

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single copies of the draft guidance to the Division of Drug Information 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 (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The 
draft guidance may also be obtained by mail by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the guidance: Paul J. Seligman, Center for Drug 
Evaluation and Research (HFD-030), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-6276, 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 
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 November 2003, the ICH Steering Committee agreed that a draft 
guidance entitled ``E2E Pharmacovigilance Planning'' should be made 
available for public comment. The draft guidance is the product of the 
Efficacy E2E Expert Working Group of the ICH. Comments about this draft 
will be considered by FDA and the Efficacy E2E Expert Working Group.
    The draft guidance describes a method for summarizing the 
identified risks of a drug, the potential for important unidentified 
risks, and the potentially at-risk populations and situations that were 
not studied before the drug was approved. The draft guidance is 
intended to foster better and earlier planning of pharmacovigilance 
activities, especially in preparation for the early postmarketing 
period of a new drug.
    The draft guidance proposes a structure for a pharmacovigilance 
plan and sets out principles of good practice for the design and 
conduct of observational studies. The draft guidance does not describe 
other methods to reduce risks from drugs, such as risk communication.
    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 regarding this 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: March 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-7105 Filed 3-29-04; 8:45 am]
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