[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34354-34355]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12658]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Clinical Chemistry and Clinical Toxicology Devices Panel of the 
Medical Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Clinical Chemistry and 
Clinical Toxicology Devices Panel of the Medical Devices Advisory 
Committee. The general function of the committee is to provide advice 
and recommendations to the Agency on FDA's regulatory issues. The 
meeting will be open to the public.

DATES: The meeting will be held on August 10, 2016, from 8 a.m. to 6 
p.m.

ADDRESSES: Gaithersburg Holiday Inn, Ballroom, Two Montgomery Village 
Ave., Gaithersburg, MD 20879. The hotel's telephone number is 301-948-
8900. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio G. Garcia, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1611, Silver Spring, MD 20993-0002, 
[email protected], 301-796-6875, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.

SUPPLEMENTARY INFORMATION: Agenda: On August 10, 2016, the committee 
will discuss, make recommendations, and

[[Page 34355]]

vote on information regarding a de novo request for the SEEKER Newborn 
Screening System (SEEKER System), by Baebies, Inc. The SEEKER System 
consists of the SEEKER Analyzer, the SEEKER 4-Plex Assay Kit, the 
SEEKER Cartridges, the Spot Logic software, and quality control 
materials; it uses digital microfluidic technology to measure multiple 
lysosomal enzymatic activities quantitatively from newborn dried blood 
spot specimens. The proposed Indication for Use for the SEEKER System 
device, as stated in the de novo request, is as follows:
    The SEEKER System is intended for quantitative measurement of the 
activity of multiple lysosomal enzymes from newborn dried blood spot 
specimens. Reduced activity of these enzymes may be indicative of a 
lysosomal storage disorder. The enzymes measured using the SEEKER 4-
Plex Assay Kit and their associated lysosomal storage disorder are 
listed in the following table.

 
------------------------------------------------------------------------
         Enzyme (abbreviation)                       Disorder
------------------------------------------------------------------------
[alpha]-L-iduronidase (IDUA)...........  Mucopolysaccharidosis Type I
                                          (MPS I) disease.
[alpha]-D-glucosidase (GAA)............  Pompe disease.
[beta]-glucocerebrosidase (GBA)........  Gaucher disease.
[alpha]-D-galactosidase A (GLA)........  Fabry disease.
------------------------------------------------------------------------

    Reduced activity for any of the four enzymes must be confirmed by 
other confirmatory diagnostic methods.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
August 3, 2016. On August 10, 2016, oral presentations from the public 
will be scheduled between approximately 1 p.m. and 2 p.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before July 
26, 2016. Time allotted for each presentation may be limited. If the 
number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by July 27, 2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact AnnMarie Williams at [email protected] or 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 24, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-12658 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P