[Federal Register Volume 71, Number 77 (Friday, April 21, 2006)]
[Notices]
[Pages 20707-20708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


MicroArray Quality Control Project on the Evaluation of Analysis 
Protocols for Deoxyribonucleic Acid Microarray Data

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of solicitation.

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SUMMARY:  The Food and Drug Administration (FDA) is soliciting gene 
expression datasets from deoxyribonucleic acid (DNA) microarray 
studies, as well as proposals to analyze these datasets in order to 
evaluate the impact of different analysis protocols on the selection of 
genes and their associated signatures for biomarker pattern 
development. This project is being coordinated by FDA as a followup to 
the MicroArray Quality Control (MAQC) Project. This evaluation process 
is open to the public.

DATES:  Datasets and proposals for participation in the project must be 
received by the National Center for Toxicological Research on or before 
4:30 p.m. c.s.t. on May 31, 2006, or be postmarked on or before May 31, 
2006.

ADDRESSES:  Datasets and proposals should be sent to Leming Shi, 
National Center for Toxicological Research, Food and Drug 
Administration, 3900 NCTR Rd., Jefferson, AR 72079, 870-543-7387, FAX: 
870-543-7686; e-mail: [email protected].

SUPPLEMENTARY INFORMATION: FDA's Critical Path Initiative (http://www.fda.gov/oc/initiatives/criticalpath) identifies pharmacogenomics as 
a key opportunity in advancing medical product development and 
personalized medicine. FDA issued the ``Guidance for Industry: 
Pharmacogenomic Data Submissions'' (http://www.fda.gov/cder/guidance/6400fnl.pdf) to facilitate scientific progress in the field of 
pharmacogenomic data integration in drug development and medical 
diagnostics.
    A microarray is a tool for analyzing gene expression. It consists 
of a small membrane or glass slide containing samples of many genes 
arranged in a regular pattern. DNA is a nucleic acid--usually in the 
form of a double helix--that contains the genetic instructions 
specifying the biological development of all cellular forms of life and 
most viruses. DNA microarray is a collection of microscopic DNA spots 
attached to a solid surface, such as glass, plastic or silicon chip 
forming an array. DNA microarrays represent a core technology in 
pharmacogenomics and toxicogenomics; however, before this technology 
can be reliably applied in clinical practice and regulatory 
decisionmaking, further evaluation is needed of the process for the 
analysis of hybridization data that results in predictive signatures.
    The MAQC project involves six FDA centers, major providers of 
microarray platforms and ribonucleic acid (RNA) samples, government 
agencies, academic laboratories, and other

[[Page 20708]]

stakeholders. The MAQC project will work with participating scientists 
to develop baseline practices for the analysis of hybridization data. 
Original datasets, analyses, and conclusions from this project will be 
made available to the public throughout the project. For more 
information about the MAQC project, please visit http://www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/.

    Dated: April 13, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-5995 Filed 4-20-06; 8:45 am]
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