Companion to Guidance for Industry on Pharmacogenomic Data; 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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Pharmacogenomic Data Submissions—Companion Guidance.” The guidance is intended as a companion to the guidance of the same name, which was issued in 2005 (70 FR 14698; March 23, 2005). It reflects experience gained since the issuance of that guidance with voluntary genomic data submissions as well as with review by FDA of numerous protocols and data submitted under investigational new drug (IND) applications, new drug applications (NDAs), and biologics license applications (BLAs). The recommendations are intended to facilitate scientific progress in the field of pharmacogenomics and to facilitate the use of pharmacogenomic data in drug development.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by November 27, 2007.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Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one self-addressed adhesive label to assist that 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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.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 either http://www.fda.gov/dockets/ecomments or http://www.regulations.gov . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Federico Goodsaid, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 3663, Silver Spring, MD 20903-0002, 301-796-1535.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance, which is intended to be used as a companion to the guidance issued in March 2005 entitled “Pharmacogenomic Data Submissions.” This draft guidance entitled “Pharmacogenomic Data Submissions—Companion Guidance” is based on FDA's experience with voluntary genomic data submissions as well as with its review of numerous protocols and data submitted under IND applications, NDAs, and BLAs during the last 2 years. FDA believes that the recommendations in the draft guidance will benefit sponsors considering the submission of either voluntary genomic data or marketing submissions containing genomics data. As technology changes and more experience is gained, these recommendations may be updated.

Specifically, this draft guidance contains recommendations on gene expression data from microarrays, genotyping, genomic data in clinical study reports, genomic data from nonclinical toxicology studies, and data submission formats. Each of the sections in the guidance make recommendations on technical steps or describes report contents or formats that will facilitate the submission of genomic data to FDA. A concept paper containing the contents of this draft guidance was made available on the Genomics Web site of FDA ( http://www.fda.gov/cder/genomics/conceptpaper_20061107.pdf ) on November 2006. The concept paper was discussed at the FDA/Drug Information Association/Pharmaceutical Research and Manufacturers of America Foundation/Biotechnology Industry Organization workshop on Best Practices and Development of Standards for the Submission of Genomic Data to FDA held in Washington, DC on November 27 and 28, 2006. This draft companion guidance reflects feedback received at and since the workshop.

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 recommendations for the submission and review of genomic data. 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.

III. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm .