Notice: International Conference on Harmonisation; Guidance on E15 
Pharmacogenomics Definitions and Sample Coding; Availability

Federal Register: April 8, 2008 (Volume 73, Number 68)           
                  Page 19074-19076

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``E15 Definitions for Genomic 
Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample 
Coding Categories.'' The guidance was prepared

[[Page 19075]]

under the auspices of the International Conference on Harmonisation of 
Technical Requirements for Registration of Pharmaceuticals for Human 
Use (ICH). The 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 guidance is intended to facilitate the 
integration of the discipline of pharmacogenomics and pharmacogenetics 
into global drug development and approval processes.

DATES:  Submit written or electronic comments on agency guidance at any 
time.

ADDRESSES:  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, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002; 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 
guidance may also be obtained by mail by calling CBER at 1-800-835-4709 
or 301-827-1800. Send two self-addressed adhesive labels to assist the 
office in processing your requests. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    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

    FDA is announcing the availability of a guidance entitled ``E15 
Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, 
Genomic Data and Sample Coding Categories.'' 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 the Federal Register of January 8, 2007 (72 FR 793), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``E15 Terminology in Pharmacogenomics.'' The notice gave 
interested persons an opportunity to submit comments by April 9, 2007.
    After consideration of the comments received and revisions to the 
guidance, a final version of the draft guidance was submitted to the 
ICH Steering Committee and endorsed by the three participating 
regulatory agencies in October 25, 2006.
    The 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 guidance provides definitions of key terms in the discipline of 
pharmacogenomics and pharmacogenetics, namely genomic biomarkers, 
pharmacogenomics, pharmacogenetics, and genomic data and sample coding 
categories. The guidance is intended to facilitate the integration of 
the discipline of pharmacogenomics and pharmacogenetics into global 
drug development and approval processes. Timely harmonization of 
terminology and definitions will create a common foundation for future 
guidance on pharmacogenomics.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The 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 submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic

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comments or submissions will be accepted by FDA through FDMS only.

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, 
or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/publications.htm. 

    Dated: March 28, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-7237 Filed 4-7-08; 8:45 am]

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