SEQC-The Sequencing Quality Control Project, 78816 [E8-30410]

Download as PDF 78816 Federal Register / Vol. 73, No. 247 / Tuesday, December 23, 2008 / Notices approved under OMB control number 0910–0485. The latex allergy caution required by 21 CFR 801.437 and referenced in the guidance does not constitute a ‘‘collection of information’’ under the PRA. Rather, it is a ‘‘public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public.’’ (5 CFR 1320.3(c)(2)). natural extension of the MicroArray Quality Control (MAQC) project (https:// www.fda.gov/nctr/science/centers/ toxicoinformatics/maqc/) and is being coordinated by the FDA. This project is open to the public. Vendors of nextgeneration sequencing technologies and institutions interested in the generation, management, analysis, and interpretation of the resulting sequence data are welcome to participate. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. 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. Dated: December 16, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–30586 Filed 12–22–08; 8:45 am] BILLING CODE 4160–01–S 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. 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 VerDate Aug<31>2005 16:29 Dec 22, 2008 Jkt 217001 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. ADDRESSES: FDA’s Critical Path Initiative (https:// 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’’ (https://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, nextgeneration 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 nextgeneration sequencing technologies. SUPPLEMENTARY INFORMATION: Dated: December 17, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–30410 Filed 12–22–08; 8:45 am] BILLING CODE 4160–01–S PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict Panel for BGES and BMRD. Date: January 7, 2009. Time: 1 p.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call) Contact Person: Scott Osborne, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4114, MSC 7816, Bethesda, MD 20892, (301) 435– 1782, osbornes@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, IMM Member Application Review. Date: January 9, 2009. Time: 10 a.m. to 12 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call) Contact Person: Cathleen L. Cooper, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4208, MSC 7812, Bethesda, MD 20892, 301–435– 3566, cooperc@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel, Epidemiology of Chronic and Acute Outcomes. Date: January 15, 2009. Time: 10:30 a.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. E:\FR\FM\23DEN1.SGM 23DEN1

Agencies

[Federal Register Volume 73, Number 247 (Tuesday, December 23, 2008)]
[Notices]
[Page 78816]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 (https://
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 (https://
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'' (https://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]
BILLING CODE 4160-01-S

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