81 FR 34355 - Sequencing Quality Control II; Public Workshop
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 104 (May 31, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 104 (May 31, 2016)
| Page Range | 34355-34356 | |
| FR Document | 2016-12656 |
[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)] [Notices] [Pages 34355-34356] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-12656] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices 34355
vote on information regarding a de novo microfluidic technology to measure of multiple lysosomal enzymes from
request for the SEEKER Newborn multiple lysosomal enzymatic activities newborn dried blood spot specimens.
Screening System (SEEKER System), by quantitatively from newborn dried Reduced activity of these enzymes may
Baebies, Inc. The SEEKER System blood spot specimens. The proposed be indicative of a lysosomal storage
consists of the SEEKER Analyzer, the Indication for Use for the SEEKER disorder. The enzymes measured using
SEEKER 4-Plex Assay Kit, the SEEKER System device, as stated in the de novo the SEEKER 4-Plex Assay Kit and their
Cartridges, the Spot Logic software, and request, is as follows: associated lysosomal storage disorder
quality control materials; it uses digital The SEEKER System is intended for are listed in the following table.
quantitative measurement of the activity
Enzyme (abbreviation) Disorder
a-L-iduronidase (IDUA) ............................................................ Mucopolysaccharidosis Type I (MPS I) disease.
a-D-glucosidase (GAA) ............................................................ Pompe disease.
b-glucocerebrosidase (GBA) .................................................... Gaucher disease.
a-D-galactosidase A (GLA) ...................................................... Fabry disease.
Reduced activity for any of the four Persons attending FDA’s advisory Quality Control II.’’ The purpose of the
enzymes must be confirmed by other committee meetings are advised that the public workshop is to define the scope
confirmatory diagnostic methods. Agency is not responsible for providing of project and study designs, and solicit
FDA intends to make background access to electrical outlets. participation of DNA sequencing
material available to the public no later FDA welcomes the attendance of the community and stakeholders for data
than 2 business days before the meeting. public at its advisory committee generation, management, analysis, and
If FDA is unable to post the background meetings and will make every effort to interpretation.
material on its Web site prior to the accommodate persons with disabilities. DATES: The public workshop will be
meeting, the background material will If you require accommodations due to a held on September 13 and 14, 2016,
be made publicly available at the disability, please contact AnnMarie from 8 a.m. to 5 p.m. See the
location of the advisory committee Williams at AnnMarie.Williams@ SUPPLEMENTARY INFORMATION section for
meeting, and the background material fda.hhs.gov or 301–796–5966 at least 7 registration date and information.
days in advance of the meeting. ADDRESSES: The public workshop will
will be posted on FDA’s Web site after
FDA is committed to the orderly be held at Wilson Hall, Bldg. 1, National
the meeting. Background material is
conduct of its advisory committee Institutes of Health (NIH), 31 Center Dr.,
available at http://www.fda.gov/
meetings. Please visit our Web site at Bethesda, MD 20892. Entrance for the
AdvisoryCommittees/Calendar/
http://www.fda.gov/ public workshop participants (non-NIH
default.htm. Scroll down to the
AdvisoryCommittees/ employees) is through the NIH Gateway
appropriate advisory committee meeting
AboutAdvisoryCommittees/ Center where routine security check
link.
ucm111462.htm for procedures on procedures will be performed. For
Procedure: Interested persons may public conduct during advisory parking and security information, please
present data, information, or views, committee meetings. refer to https://www.nih.gov/about-nih/
orally or in writing, on issues pending Notice of this meeting is given under visitor-information/campus-access-
before the committee. Written the Federal Advisory Committee Act (5 security.
submissions may be made to the contact U.S.C. app. 2).
person on or before August 3, 2016. On FOR FURTHER INFORMATION CONTACT:
Dated: May 24, 2016. Weida Tong, National Center for
August 10, 2016, oral presentations from
Jill Hartzler Warner, Toxicological Research (NCTR), Food
the public will be scheduled between
Associate Commissioner for Special Medical and Drug Administration, 3900 NCTR
approximately 1 p.m. and 2 p.m. Those
Programs. Rd., Jefferson, AR 72079, 870–543–7142,
individuals interested in making formal
oral presentations should notify the [FR Doc. 2016–12658 Filed 5–27–16; 8:45 am] FAX: 870–543–7854, weida.tong@
contact person and submit a brief BILLING CODE 4164–01–P fda.hhs.gov.
statement of the general nature of the SUPPLEMENTARY INFORMATION: FDA’s
evidence or arguments they wish to Critical Path Initiative (http://
DEPARTMENT OF HEALTH AND
present, the names and addresses of www.fda.gov/oc/initiatives/criticalpath/
HUMAN SERVICES
proposed participants, and an ) identifies pharmacogenomics as a key
indication of the approximate time Food and Drug Administration opportunity in advancing medical
requested to make their presentation on product development and personalized
or before July 26, 2016. Time allotted for [Docket No. FDA–2016–N–0001] medicine. FDA has issued the
each presentation may be limited. If the ‘‘Guidance for Industry:
Sequencing Quality Control II; Public
number of registrants requesting to Pharmacogenomic Data Submissions’’
Workshop
speak is greater than can be reasonably (http://www.fda.gov/downloads/drugs/
sradovich on DSK3TPTVN1PROD with NOTICES
accommodated during the scheduled AGENCY: Food and Drug Administration, guidancecomplianceregulatory
open public hearing session, FDA may HHS. information/guidances/ucm079849.pdf)
conduct a lottery to determine the ACTION: Notice of public workshop. to facilitate scientific progress in the
speakers for the scheduled open public field of pharmacogenomic data
hearing session. The contact person will SUMMARY: The Food and Drug integration in drug development and
notify interested persons regarding their Administration (FDA) is announcing a medical diagnostics. Microarrays
request to speak by July 27, 2016. public workshop entitled ‘‘Sequencing represent a core technology in
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![34356 Federal Register / Vol. 81, No. 104 / Tuesday, May 31, 2016 / Notices
pharmacogenomics and toxicogenomics; ACTION: Notice. decisions based on the interstitial fluid
however, next-generation sequencing glucose concentration reported by the
technologies promise to provide some SUMMARY: The Food and Drug CGM.
unique advantages in DNA and RNA Administration (FDA) announces a On July 22, 2016, the committee will
analyses and are expected to be adopted forthcoming public advisory committee discuss and make recommendations on
by the pharmaceutical and medical meeting of the Clinical Chemistry and information regarding a premarket
industries for advancing personalized Clinical Toxicology Devices Panel of the notification (510(k)) submission for the
nutrition and medicine. Medical Devices Advisory Committee. Alere AfinionTM HbA1c Dx point-of-care
Starting in 2005, FDA initiated an The general function of the committee is test system, sponsored by Alere
open project, MicroArray Quality to provide advice and recommendations Technologies AS. The proposed
Control (MAQC), which has gone to the Agency on FDA’s regulatory intended use, as stated by the sponsor:
through three phases. MAQC–I focused issues. The meeting will be open to the
public. Alere Afinion HbA1c Dx is an in vitro
on the technical aspects of microarray- diagnostic test for quantitative determination
based gene expression measurements, DATES: The meeting will be held on July of glycated hemoglobin (% hemoglobin A1c,
the MAQC–II focused on validation of 21 and July 22, 2016, from 8 a.m. to 6 HbA1c) in human whole blood. This test is
microarray-based predictive models, p.m. to be used as an aid in the diagnosis of
and MAQC–III, which is also called the ADDRESSES: Hilton Washington DC diabetes and as an aid in identifying patients
Sequencing Quality Control (SEQC), North/Gaithersburg, Salons A, B, C, and who may be at risk for developing diabetes.
focused on assessing the performance of D, 620 Perry Pkwy., Gaithersburg, MD The measurement of % HbA1c is
20877. The hotel’s telephone number is recommended as a marker of long-term
whole transcriptome sequencing (RNA-
metabolic control in persons with diabetes
seq). 301–977–8900. Answers to commonly mellitus. For use in clinical laboratories and
The Sequencing Quality Control asked questions including information point of care laboratory settings.
Phase 2 (SEQC–II) is a natural extension regarding special accommodations due
of the SEQC project with emphasis on to a disability, visitor parking, and Current clinical guidelines
DNA-Seq for various applications. The transportation may be accessed at: contraindicate the use of point-of-care
SEQC–II project, with broad http://www.fda.gov/ hemoglobin A1c (HbA1c) tests to
participation from scientists and AdvisoryCommittees/ diagnose diabetes. FDA is seeking
reviewers within FDA and collaborators AboutAdvisoryCommittees/ feedback from the clinical community to
across the public, academic, and private ucm408555.htm. determine significant, scientific and
sectors, is expected to help prepare FDA practical, reservations or support for
FOR FURTHER INFORMATION CONTACT:
for the next wave of submission of using this point-of-care HbA1c test as an
Patricio Garcia, Center for Devices and aid in the diagnosis of diabetes and pre-
genomic data generated from the next- Radiological Health, Food and Drug
generation sequencing technologies. diabetes.
Administration, Bldg. 66, Rm. 1116, FDA intends to make background
Registration: Mail, fax, or email your
10903 New Hampshire Ave., Silver material available to the public no later
registration information (including
Spring, MD 20993; patricio.garcia@ than 2 business days before the meeting.
name, title, firm name, address,
fda.hhs.gov; 301–796–6875, or FDA If FDA is unable to post the background
telephone, and fax numbers) to the
Advisory Committee Information Line, material on its Web site prior to the
contact person by August 31, 2016. FDA
1–800–741–8138 (301–443–0572 in the meeting, the background material will
will email a confirmation to those who
have registered. There is no registration Washington, DC area). A notice in the be made publicly available at the
fee for the public workshop. Early Federal Register about last minute location of the advisory committee
registration is recommended because modifications that impact a previously meeting, and the background material
seating is limited. No registration on the announced advisory committee meeting will be posted on FDA’s Web site after
day of the public workshop will be cannot always be published quickly the meeting. Background material is
provided. enough to provide timely notice. available at http://www.fda.gov/
If you need special accommodations Therefore, you should always check the AdvisoryCommittees/Calendar/
due to a disability, please contact Weida Agency’s Web site at http:// default.htm. Scroll down to the
Tong (see FOR FURTHER INFORMATION www.fda.gov/AdvisoryCommittees/ appropriate advisory committee meeting
CONTACT) at least 7 days in advance. default.htm and scroll down to the link.
appropriate advisory committee meeting Procedure: Interested persons may
Dated: May 24, 2016.
link, or call the advisory committee present data, information, or views,
Leslie Kux, information line to learn about possible orally or in writing, on issues pending
Associate Commissioner for Policy. modifications before coming to the before the committee. Written
[FR Doc. 2016–12656 Filed 5–27–16; 8:45 am] meeting. submissions may be made to the contact
BILLING CODE 4164–01–P
SUPPLEMENTARY INFORMATION: person on or before July 15, 2016. Oral
Agenda: On July 21, 2016, the presentations from the public will be
committee will discuss, make scheduled on July 21 and 22, 2016,
DEPARTMENT OF HEALTH AND
recommendations, and vote on between approximately 1 p.m. and 2
HUMAN SERVICES
information regarding a premarket p.m. Those individuals interested in
Food and Drug Administration approval application (PMA) panel-track making formal oral presentations should
supplement for a proposed change in notify the contact person and submit a
[Docket No. FDA–2016–N–0001] intended use of Dexcom, Inc.’s, Dexcom brief statement of the general nature of
sradovich on DSK3TPTVN1PROD with NOTICES
G5® Mobile Continuous Glucose the evidence or arguments they wish to
Clinical Chemistry and Clinical
Monitoring System (CGM) device so present, the names and addresses of
Toxicology Devices Panel of the
that, in addition to tracking and proposed participants, and an
Medical Devices Advisory Committee;
trending interstitial fluid glucose indication of the approximate time
Notice of Meeting
concentrations, patients can use the requested to make their presentation on
AGENCY: Food and Drug Administration, device as a replacement for their blood or before July 7, 2016. Time allotted for
HHS. glucose meters and make treatment each presentation may be limited. If the
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Document Created: 2016-05-28 03:57:19
Document Modified: 2016-05-28 03:57:19
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop. | |
| 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. | |
| 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] | |
| FR Citation | 81 FR 34355 |
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