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###### Department of Health and Human Services

###### Food and Drug Administration

          - [Docket No. FDA-2009-D-0324]

# AGENCY:

 Food and Drug Administration, HHS.

# ACTION:

 Notice.

# SUMMARY:

 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.” The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers. The draft guidance is intended to foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities. 

# DATES:

 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by September 28, 2009.

# ADDRESSES:

                         Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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, Outreach and Development (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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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://      ( print page 38034)    www.regulations.gov*. See the                         **SUPPLEMENTARY INFORMATION**                         section for electronic access to the draft guidance document.                    

# FOR FURTHER INFORMATION CONTACT:

*Regarding the guidance*: Federico Goodsaid, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2148, Silver Spring, MD 20903-0002, 301-796-1535; or Jennifer Catalano, Center for Biologics Evaluation and Research (HFM-735), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0706.                    

*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 June 2009, the ICH Steering Committee agreed that a draft guidance entitled “E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions” should be made available for public comment. The draft guidance is the product of the E16 Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the E16 Expert Working Group.

The use of biomarkers in drug discovery, development, and postapproval has the potential to facilitate development of safer and more effective medicines, to guide dose selection, and to enhance the benefit-risk profile of approved medicines. This draft guidance describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers. To support the evaluation of genomic biomarkers, the draft guidance describes and defines a submission standard applicable across regions. The recommendations are based on previous experiences in the various regions with submissions containing genomic biomarker data. Such submissions have been either stand-alone biomarker qualification applications or a component of medicinal product-related regulatory process. Where appropriate, the proposed document format is expected to facilitate incorporation of genomic biomarker data into specific product-related applications.

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.regulations.gov*,                     *http://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm*, or                     *http://www.fda.gov/​BiologicsBloodVaccines/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm*.                

Dated: July 23, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

[FR Doc. E9-18227 Filed 7-29-09; 8:45 am]

BILLING CODE 4160-01-S