[Federal Register Volume 73, Number 247 (Tuesday, December 23, 2008)]
[Notices]
[Page 78816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-30410]
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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: [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 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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