Document ID: FDA-2008-N-0644-0001
Agency: fda
Document Type: Notice
Title: SEQC--The Sequencing Quality Control Project
Posted Date: 2008-12-23T05:00Z

[Federal Register: December 23, 2008 (Volume 73, Number 247)]
[Notices]               
[Page 78816]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de08-99]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0644]

 
SEQC--The Sequencing Quality Control Project

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of solicitation.

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SUMMARY: The Food and Drug Administration (FDA) is soliciting 
volunteers to participate in the SEQC (Sequencing Quality Control) 
project to objectively assess the technical performance of different 
next-generation sequencing technologies in DNA (deoxyribonucleic acid) 
and RNA (ribonucleic acid) analyses and to evaluate the advantages and 
limitations of various bioinformatics solutions in handling and 
analyzing the massive new data sets. The SEQC project is a natural 
extension of the MicroArray Quality Control (MAQC) project (http://
www.fda.gov/nctr/science/centers/toxicoinformatics/maqc/) and is being 
coordinated by the FDA. This project is open to the public. Vendors of 
next-generation sequencing technologies and institutions interested in 
the generation, management, analysis, and interpretation of the 
resulting sequence data are welcome to participate.

DATES: Requests to participate in the SEQC project at the National 
Center for Toxicological Research (NCTR) should be submitted on or 
before 4:30 p.m., CST, January 9, 2009, or be postmarked on or before 
January 9, 2009.

ADDRESSES: Requests to participate in the SEQC project 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: 870-543-7854; e-mail: leming.shi@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 has 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.
    Microarrays represent a core technology in pharmacogenomics and 
toxicogenomics; however, next-generation sequencing technologies 
promise to provide some unique advantages in DNA and RNA analyses and 
are expected to be adopted by the pharmaceutical and medical industries 
for advancing personalized nutrition and medicine.
    The SEQC project, with broad participation from scientists and 
reviewers within FDA and collaborators across the public, academic, and 
private sectors, is expected to help prepare FDA for the next wave of 
submission of genomic data generated from the next-generation 
sequencing technologies.

    Dated: December 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30410 Filed 12-22-08; 8:45 am]

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