[BioC] FDA soliciting proposals to analyze gene expression datasets

[Wolfgang Huber]

Hi bioconductors,

this may be of interest to some:
(see also http://www.gpoaccess.gov/fr/index.html)

  Cheers, Wolfgang

=========================================================================


[Federal Register: April 21, 2006 (Volume 71, Number 77)]
[Notices]
[Page 20707-20708]
 From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ap06-68]

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

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.

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

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: leming.shi at fda.hhs.gov.

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]
BILLING CODE 4160-01-S