**Federal Register **/ Vol. 70, No. 204 / Monday, October 24, 2005 /
Notices **61457**

please contact Jeannette Coleman at 870--543--7087, * *at least 7 days
in advance of the meeting.

**SUPPLEMENTARY INFORMATION: **FDA's

critical path initiative *(http://*

* ) *identifies pharmacogenomics as a key opportunity in advancing
medical product development and personalized medicine. FDA issued the
''Guidance for Industry: Pharmacogenomic Data Submissions'' *(
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 time­polymerase 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 * sci en ce/cen
ters/toxi coin f orm a ti cs/ 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**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES**

**National Institutes of Health**

**Proposed Collection; Comment Request; Injuries Among Youth With
Developmental Disabilities**

**SUMMARY: **In compliance with the

requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of
1995, for opportunity for public comment on proposed data collection
projects, the National Institute of Child Health and Human Development
(NICHD), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.

**Proposed Collection**

*Title: *Injuries Among Youth with Developmental Disabilities. *Type of
Information Collection Request: *New. *Use of Information: *The proposed
study seeks (1) to determine if children with disabilities are at
increased risk of injury compared to typically developing children, and
(2) to identify which injuries children with developmental disabilities
are at particular risk of sustaining. Existing data on this topic are
scarce and equivocal. Results will help inform prevention efforts. NICHD
proposes to collect information about disabilities among children with
injuries through phone interviews with