[Federal Register Volume 72, Number 4 (Monday, January 8, 2007)]
[Notices]
[Pages 793-794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0526]


International Conference on Harmonisation; Draft Guidance on E15 
Terminology in Pharmacogenomics; 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availability of a draft guidance entitled ``E15 Terminology in 
Pharmacogenomics.'' The draft guidance was prepared under the auspices 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The draft guidance contains definitions of key terms in the discipline 
of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, 
pharmacogenomics, pharmacogenetics, and genomic data and sample coding 
categories. In the effort to develop harmonized approaches to drug 
regulation, it is important to ensure that consistent definitions of 
terminology are being applied across all constituents of the ICH. The 
draft guidance is intended facilitate the integration of the discipline 
of pharmacogenomics and pharmacogenetics into global drug development 
and approval processes.

DATES:  Submit written or electronic comments on the draft guidance by 
April 9, 2007.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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 The draft guidance may also be obtained by 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 CBER at 1-800-835-4709 or 301-827-1800. Send two self-
addressed labels to assist the office in processing your requests. 
Submit written comments on the draft guidance to the Division of 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. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section

[[Page 794]]

for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Felix Frueh, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
21, rm. 4512, Silver Spring, MD 20993-0002, 301-796-1530; or
    Raj K. Puri, Center for Biologics Evaluation and Research (HFM-
735), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-0471.
    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 October 2006, the ICH Steering Committee agreed that a draft 
guidance entitled ``E15 Terminology in Pharmacogenomics'' should be 
made available for public comment. The draft guidance is the product of 
the E15 Pharmacogenomics Expert Working Group of the ICH. Comments 
about this draft will be considered by FDA and the E15 Pharmacogenomics 
Expert Working Group.
    The draft guidance represents an international effort to harmonize 
pharmacogenomics definitions and sample coding. Inconsistent 
definitions make it difficult to achieve agreement on parameters for 
implementation of pharmacogenomics in global pharmaceutical 
development, and might lead to inconsistent assessments by regulators. 
The draft guidance contains definitions of key terms in the discipline 
of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, 
pharmacogenomics, pharmacogenetics, and genomic data and sample coding 
categories. Timely harmonisation of terminology and definitions will 
create a common foundation for future guidance on pharmacogenomics.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The 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. 
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. 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: December 29, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5 Filed 1-5-07; 8:45 am]
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