[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34355-34356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Sequencing Quality Control II; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Sequencing Quality Control II.'' The purpose of the 
public workshop is to define the scope of project and study designs, 
and solicit participation of DNA sequencing community and stakeholders 
for data generation, management, analysis, and interpretation.

DATES: The public workshop will be held on September 13 and 14, 2016, 
from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public workshop will be held at Wilson Hall, Bldg. 1, 
National Institutes of Health (NIH), 31 Center Dr., Bethesda, MD 20892. 
Entrance for the public workshop participants (non-NIH employees) is 
through the NIH Gateway Center where routine security check procedures 
will be performed. For parking and security information, please refer 
to https://www.nih.gov/about-nih/visitor-information/campus-access-security.

FOR FURTHER INFORMATION CONTACT: Weida Tong, National Center for 
Toxicological Research (NCTR), Food and Drug Administration, 3900 NCTR 
Rd., Jefferson, AR 72079, 870-543-7142, FAX: 870-543-7854, 
[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/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079849.pdf) to 
facilitate scientific progress in the field of pharmacogenomic data 
integration in drug development and medical diagnostics. Microarrays 
represent a core technology in

[[Page 34356]]

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.
    Starting in 2005, FDA initiated an open project, MicroArray Quality 
Control (MAQC), which has gone through three phases. MAQC-I focused on 
the technical aspects of microarray-based gene expression measurements, 
the MAQC-II focused on validation of microarray-based predictive 
models, and MAQC-III, which is also called the Sequencing Quality 
Control (SEQC), focused on assessing the performance of whole 
transcriptome sequencing (RNA-seq).
    The Sequencing Quality Control Phase 2 (SEQC-II) is a natural 
extension of the SEQC project with emphasis on DNA-Seq for various 
applications. The SEQC-II 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.
    Registration: Mail, fax, or email your registration information 
(including name, title, firm name, address, telephone, and fax numbers) 
to the contact person by August 31, 2016. FDA will email a confirmation 
to those who have registered. There is no registration fee for the 
public workshop. Early registration is recommended because seating is 
limited. No registration on the day of the public workshop will be 
provided.
    If you need special accommodations due to a disability, please 
contact Weida Tong (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12656 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P