[Federal Register Volume 67, Number 251 (Tuesday, December 31, 2002)]
[Notices]
[Pages 79939-79940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32979]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 96D-0041]


International Conference on Harmonisation; Draft Guidance on 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.

-----------------------------------------------------------------------

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availability of a draft guidance entitled ``Addendum to E2C Clinical 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 The draft guidance was prepared under the auspices of the 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 This draft guidance, an addendum to the ICH E2C guidance of 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 The draft guidance is intended to help 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

DATES: Submit written or electronic comments on the draft guidance by 
January 24, 2003.

ADDRESSES: You may submit written comments on the draft guidance to the 
Dockets Management Branch (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single copies of the draft guidance to the Division of Drug Information 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, 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.

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 (HFM-220), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-6090.
    Regarding the ICH: Janet Showalter, Office of International 
Programs (HFG-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0864.

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

[[Page 79940]]

sponsors are the: European Commission; European Federation of 
Pharmaceutical Industries Associations; Japanese Ministry of Health, 
Labour, and Welfare; Japanese Pharmaceutical Manufacturers Association, 
Centers for Drug Evaluation and Research and Biologics Evaluation and 
Research, FDA; and 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 accordance with FDA's good guidance practices regulation (21 CFR 
10.115), this document is being called a guidance, rather than a 
guideline.
    To facilitate the process of making ICH guidances available to the 
public, the agency has changed its procedure for publishing ICH 
guidances. As of April 2000, we no longer include the text of ICH 
guidances in the Federal Register. Instead, we publish a notice in the 
Federal Register announcing the availability of an ICH guidance. The 
ICH guidance will be placed in the docket and can be obtained through 
regular agency sources (see ADDRESSES). Draft guidances are left in the 
original ICH format. The final guidance is reformatted to conform to 
the style before publication.
    In September 2002, the ICH Steering Committee agreed that a draft 
guidance entitled ``Addendum to E2C Clinical Safety Data Management: 
Periodic Safety Update Reports for Marketed Drugs'' should be made 
available for public comment. The draft guidance is the product of the 
Efficacy Expert Working Group of the ICH focusing on pharmacovigilance 
topics. Comments about this draft will be considered by FDA and the 
Efficacy Expert Working Group.
    The ICH E2C guidance of May 19, 1997, recommends a unified standard 
for the format, content, and reporting frequency for PSURs for drug and 
biological products. This draft guidance, an addendum to the ICH E2C 
guidance, provides additional information on the objectives, general 
principles, and model for PSURs. The draft guidance includes, for 
example, recommendations regarding:
    [sbull] Synchronization of National Birthdates with the 
International Birthdates,
    [sbull] Use of the latest version of the reference safety 
information,
    [sbull] Submission of executive summaries as part of the PSUR,
    [sbull] Options to submit summary bridging reports and addendum 
reports, and
    [sbull] Handling of solicited reports.
    The document should be used in conjunction with the E2C guidance.
    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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance by 
January 24, 2003. 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 draft guidance and received comments may be seen in 
the Dockets Management Branch 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: December 23, 2002.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 02-32979 Filed 12-30-02; 8:45 am]
BILLING CODE 4160-01-S