[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Notices]
[Page 61457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21152]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


MicroArray Quality Control Project Meeting on MicroArray Quality 
Control; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``MicroArray Quality Control (MAQC) Project Meeting on 
MicroArray Quality Control.'' The focus of the 2-day meeting will be to 
review the datasets generated by the MAQC study.
    Date and Time: The meeting will be held on Thursday, December 1, 
2005, from 8 a.m. to 5 p.m. and Friday, December 2, 2005, from 8 a.m. 
to 2 p.m.
    Location: The meeting will be held at the Crowne Plaza Cabana 
Portofino Room on December 1, 2005, and the St. Tropez Room on December 
2, 2005, 4290 El Camino Real, Palo Alto, CA 94306, 650-857-0787, FAX: 
650-496-1939, Web site: http://www.cppaloalto.crowneplaza.com/. (FDA 
has verified the Web site address, but is not responsible for 
subsequent changes to the Web site after this document publishes in the 
Federal Register.)
    Contact: 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: <a href="/cdn-cgi/l/email-protection#d9b5bcb4b0b7bef7aab1b099bfbdb8f7b1b1aaf7beb6af"><span class="__cf_email__" data-cfemail="573b323a3e393079243f3e17313336793f3f2479303821">[email protected]</span></a>.
    Registration: There will be no registration fee for attending the 
meeting. However, interested parties should send registration 
information (including name, title, firm name, address, telephone, and 
fax number), and written material and requests to make oral 
presentations, to the contact person (see Contact) at least 15 days in 
advance of the meeting. Participants are responsible for their own 
costs of travel, lodging, and meals.
    FDA welcomes the attendance of the public at this meeting and will 
make every effort to accommodate persons with physical disabilities or 
special needs. If you require special accommodations due to a 
disability, please contact Jeannette Coleman at 870-543-7087, e-mail: 
<a href="/cdn-cgi/l/email-protection#84eee1e5eae1f0f0e1aae7ebe8e1e9e5eac4e2e0e5aaececf7aae3ebf2"><span class="__cf_email__" data-cfemail="38525d59565d4c4c5d165b57545d555956785e5c591650504b165f574e">[email protected]</span></a>, at least 7 days in advance of the 
meeting.

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 
pharmacogenomics and to facilitate the use of pharmacogenomic data in 
drug development and medical diagnostics. A microarray is a tool for 
analyzing gene expression that consists of a small membrane or glass 
slide containing samples of many genes arranged in a regular pattern. 
Microarrays represent a core technology in pharmacogenomics; however, 
before this technology can successfully and reliably be applied in 
clinical practice and regulatory decisionmaking, standards and quality 
measures need to be developed.
    The MAQC project involves six FDA centers, major providers of 
microarray platforms and ribonucleic acid (RNA) samples, government 
agencies, academic laboratories, and other stakeholders. The MAQC 
project aims to evaluate quality control metrics and thresholds for 
objectively assessing the performance achievable by various microarray 
platforms, and evaluating the advantages and disadvantages of various 
data analysis methods. Two RNA samples will be selected for three 
species (i.e., human, rat, and mouse), and differential gene expression 
levels between the two samples will be calibrated with microarrays and 
other technologies (e.g., quantitative real time-polymerase chain 
reaction (qRT-PCR)). The resulting microarray datasets will be used for 
assessing the precision and crossplatform/laboratory comparability of 
microarrays, and the qRT-PCR datasets will enable evaluation of the 
nature and magnitude of any systematic biases that may exist between 
microarrays and qRT-PCR. The availability of the calibrated RNA samples 
and the resulting microarray and qRT-PCR datasets, which will be made 
readily accessible to the microarray community, will allow individual 
laboratories to identify and correct procedural failures more easily. 
The MAQC project will help improve the microarray technology and foster 
its proper applications in discovery, development and review of FDA-
regulated products. For more information about the MAQC project, please 
visit http://www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/.
    At the public meeting, each participating platform provider will 
give a 15-minute presentation to summarize the datasets generated by 
its test sites and to describe its analysis results. Each analysis site 
will also give a 15-minute presentation on its analysis results. Other 
interested parties may present data, information, or views, orally or 
in writing, on issues related to microarray quality control and data 
analysis. Those desiring to make formal oral presentations should 
notify the contact person (see Contact) before November 4, 2005, and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present with an indication of the approximate 
time requested to make the presentation.

    Dated: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21152 Filed 10-21-05; 8:45 am]
BILLING CODE 4160-01-S


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