[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68432-68434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2880]


Microbiology Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting; Establishment of a Public Docket; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Microbiology 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. FDA is 
establishing a docket for public comment on this document.

DATES: The meeting will be held on November 9 and 10, 2016, from 8 a.m. 
to 6 p.m.

ADDRESSES: Gaithersburg Holiday Inn Ballroom, 2 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.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-2880 for ``Microbiology Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting; Establishment of a Public 
Docket; Request for Comments.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Silver Spring, MD 20993, [email protected], 301-796-0400, 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 November 9, 2016, during session one, the committee will

[[Page 68433]]

discuss and make recommendations regarding the reclassification of 
quantitative Cytomegalovirus (CMV) viral load devices from class III 
(Premarket approval) to class II (510(k)). A nucleic acid-based in 
vitro diagnostic device for the quantitation of CMV viral load, within 
the context of transplant patient management, is a post-amendment 
device classified into class III under section 513(f)(1) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act)(21 U.S.C. 360c(f)(1). To 
date, the following product code has been established for CMV viral 
load devices: PAB (CMV DNA Quantitative Assay). During session two, the 
committee will discuss and make recommendations regarding the 
appropriate initial classification for qualitative or quantitative 
viral load devices for Epstein-Barr virus, BK virus, JC virus, Human 
Herpesvirus 6, and Adenovirus infections. FDA is seeking expert 
recommendations to assess the potential risks and benefits of these 
devices when used in patients following solid-organ or stem cell 
transplantation.
    On November 10, 2016, the committee will discuss and make 
recommendations to FDA regarding how FDA might handle a future 
premarket notification (510(k)) submission for a Procalcitonin (PCT) 
test. One test that FDA previously reviewed and cleared was the VIDAS 
B[middot]R[middot]A[middot]H[middot]M[middot]S PCT (Procalcitonin) test 
which is an in vitro diagnostic test for measuring procalcitonin from 
human serum or plasma. The test was cleared with an indication for use 
as follows:
     VIDAS B[middot]R[middot]A[middot]H[middot]M[middot]S PCT 
(PCT) is an automated test for use on the instruments of the VIDAS 
family for the determination of human procalcitonin in human serum or 
plasma (lithium heparinate) using the Enzyme-Linked Fluorescent Assay 
technique.
     VIDAS B[middot]R[middot]A[middot]H[middot]M[middot]S PCT 
(PCT) is intended for use in conjunction with other laboratory findings 
and clinical assessments to aid in the risk assessment of critically 
ill patients on their first day of ICU admission for progression to 
severe sepsis and septic shock.
     VIDAS B[middot]R[middot]A[middot]H[middot]M[middot]S PCT 
(PCT) is also intended for use to determine the change of PCT level 
over time as an aid in assessing the cumulative 28-day risk of all-
cause mortality in conjunction with other laboratory findings and 
clinical assessments for patients diagnosed with severe sepsis or 
septic shock in the intensive care unit (ICU) or when obtained in the 
emergency department or other medical wards prior to ICU admission.
     Procalcitonin (PCT) is a biomarker associated with the 
inflammatory response to bacterial infection that aids in the risk 
assessment of critically ill patients on their first day of ICU 
admission for progression to severe sepsis and septic shock. The 
percent change in PCT level over time also aids in the prediction of 
cumulative 28-day mortality in patients with severe sepsis and septic 
shock.
    PCT levels on the first day of ICU admission above 2.0 nanograms 
per milliliter (ng/mL) are associated with a higher risk for 
progression to severe sepsis and/or septic shock than PCT levels below 
0.5 ng/mL.
     A PCT level that declines <=80 percent from the day that 
severe sepsis or septic shock was clinically diagnosed (day 0) to 4 
days after clinical diagnosis (day 4) is associated with higher 
cumulative 28-day risk of all-cause mortality than a decline >80 
percent.
     The combination of the first PCT level (<=2.0 ng/mL or 
>2.0 ng/mL) at initial diagnosis of severe sepsis or septic shock with 
the patient's clinical course and the change in PCT level over time 
until day 4 provides important additional information about the 
mortality risk.
     The PCT level on day 1 (the day after severe sepsis or 
septic shock is first clinically diagnosed) can be used to calculate 
the percent change in PCT level at day 4 if the day 0 measurement is 
unavailable.
    FDA anticipates receiving a 510(k) submission for PCT test in which 
the intended use could be modified to add an indication for use as an 
aid in the antibiotic management of patients with suspected lower 
respiratory tract infection, an indication for use as an aid in the 
antibiotic management of patients being treated with antibiotics for 
confirmed or documented sepsis, or both. FDA is seeking feedback from 
the committee and interested parties to assess the evidence in support 
of the hypothetical changes and the overall benefits and risks from 
this proposed new indication for use in clinical practice, including 
feedback on whether any additional mitigations are necessary.
    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 
October 27, 2016. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. and 9:30 a.m. on November 9, 2016, and 
between approximately 1 p.m. and 2 p.m. on November 10, 2016. 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 
October 19, 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 October 20, 
2016.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA is establishing a docket for public comment on this document. 
The docket number is FDA-2016-N-2880. The docket will close on December 
6, 2016. Comments received on or before October 26, 2016, will be 
provided to the committee. Comments received after that date will be 
taken into consideration by the Agency.
    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 Artair Mallett at [email protected] or 301-796-9638, 
at least 7 days in advance of the meeting. For press inquiries, please 
contact the Office of Media Affairs at [email protected] or 301-796-
4540.
    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.

[[Page 68434]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 28, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-23895 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P