[Federal Register Volume 72, Number 167 (Wednesday, August 29, 2007)]
[Notices]
[Pages 49722-49723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-17103]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0310]


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

[[Page 49723]]

availability of a draft guidance entitled ``Pharmacogenomic Data 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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INFORMATION section for electronic access to the draft guidance 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.

    Dated: August 23, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-17103 Filed 8-28-07; 8:45 am]
BILLING CODE 4160-01-S