81 FR 12511 - Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices; Public Workshop; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 46 (March 9, 2016)

The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices.'' The topics to be discussed are the specific analytical and clinical study designs and considerations for validation and use of liquid chromatography/mass- spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the clinical laboratory. The primary focus will be on the validation considerations with protein- and peptide-based LC/MS devices.

[Federal Register Volume 81, Number 46 (Wednesday, March 9, 2016)]
[Notices]
[Pages 12511-12513]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-05220]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0610]


Mass Spectrometry in the Clinic: Regulatory Considerations 
Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based 
Devices; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Mass Spectrometry in the Clinic: 
Regulatory Considerations Surrounding Validation of Liquid 
Chromatography-Mass Spectrometry Based Devices.'' The topics to be 
discussed are the specific analytical and clinical study designs and 
considerations for validation and use of liquid chromatography/mass-
spectrometry (LC/MS)-based in vitro diagnostic devices (IVDs) in the 
clinical laboratory. The primary focus will be on the validation 
considerations with protein- and peptide-based LC/MS devices.

DATES: The public workshop will be held on May 2, 2016, from 8:30 a.m. 
to 5 p.m. Submit either electronic or written comments on the public 
workshop by April 20, 2016.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver 
Spring, MD 20993. Entrance for the public meeting participants (non-FDA 
employees) is through Building 1, where routine security check 
procedures will be performed. For parking and security information, 
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.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,

[[Page 12512]]

if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-0610 for the ``Mass Spectrometry in the Clinic: Regulatory 
Considerations Surrounding Validation of Liquid Chromatography-Mass 
Spectrometry Based Devices'' public workshop. 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: Julia Tait Lathrop, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5614, Silver Spring, MD 20993, 240-402-
5034, email: [email protected].

I. Background

    Innovations in liquid chromatography-mass spectrometry (LC/MS) 
technology have dramatically improved assay throughput and 
precision.\1\ FDA has cleared and approved several LC/MS- and MS-based 
devices as diagnostic tests, including assays for screening newborns 
for metabolic diseases, for identifying microbes from human cultures, 
and for measuring the concentrations of therapeutic drugs in blood. 
Currently, however, no LC/MS-based IVDs have been cleared or approved 
by FDA for measuring proteins and peptides. FDA would like to enhance 
engagement with the clinical LC/MS community concerning the development 
and validation of LC/MS-based devices and to work with the community 
toward developing guidelines for review that will be useful and 
relevant to both FDA and manufacturers. Prior to the workshop, FDA will 
place a discussion paper on file in the public docket (docket number 
found in brackets in the heading of this document) and will post it at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
---------------------------------------------------------------------------

    \1\ LC/MS includes high-performance liquid chromatography, HPLC-
MS.
---------------------------------------------------------------------------

II. Topics for Discussion

    This public workshop will consist of brief presentations providing 
information to frame the goals of the workshop, followed by interactive 
panel discussions. The presentations will focus on current and 
anticipated uses for LC/MS and discussions of different validation 
approaches. Following the presentations, a moderated discussion will 
ask speakers and additional panelists to provide their individual 
perspectives. Examples of topics for discussion surrounding the 
challenges to validation that are specific to LC/MS-based protein and 
peptide IVDs include:
     Identifying pre-analytical and analytical variables that 
impact precision and reproducibility;
     Defining methods of normalization, harmonization, and the 
use of internal standards for quantitation and device calibration;
     Developing quality control materials; and
     Identifying appropriate reference materials and predicate 
devices.
    We are soliciting comments and feedback from the clinical LC/MS 
community regarding additional topics for FDA to consider. We 
anticipate that the comments and suggestions generated through this 
workshop will help facilitate the development of appropriate analytical 
and clinical validation methods for IVDs. The agenda of the workshop 
will include time for public comments. These comments can be submitted 
to the docket prior to the meeting (see ADDRESSES).
    Registration: Registration is free and early registration is 
recommended because facilities are limited and, therefore, FDA may 
limit the number of participants from each organization. Persons 
interested in attending this public workshop must register online by 4 
p.m. on April 22, 2016. If time and space permit, onsite registration 
on the day of the public workshop will be provided beginning at 7:30 
a.m.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, 301-796-5661, [email protected], no 
later than April 15, 2016.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone number. Those without 
Internet access should contact Susan Monahan (contact for special 
accommodations) to register. Registrants will receive confirmation 
after they have been accepted. You will be notified if you are on a 
waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. The Webcast link will be available on the registration 
Web page after April 25, 2016. If you have never attended a Connect Pro 
event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the 
Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. 
FDA has verified the Web site addresses in this document, as of the 
date this document publishes in the Federal Register, but Web sites are 
subject to change over time.
    Requests for Oral Presentations: This public workshop includes a 
public comment session and topic-focused sessions. During online 
registration you may indicate if you wish to present during a public 
comment session or

[[Page 12513]]

participate in a specific session, and which topics you wish to 
address. FDA has included general topics in this document. FDA will do 
its best to accommodate requests to make public comments and 
participate in the focused sessions. Individuals and organizations with 
common interests are urged to consolidate or coordinate their 
presentations, and request time for a joint presentation, or submit 
requests for designated representatives to participate in the focused 
sessions. Following the close of registration, FDA will determine the 
amount of time allotted to each presenter and the approximate time each 
oral presentation is to begin, and will select and notify participants 
by April 24, 2016. All requests to make oral presentations must be 
received by the close of registration at 4 p.m. on April 22, 2016. If 
selected for presentation, any presentation materials must be emailed 
to Julia Tait Lathrop (see FOR FURTHER INFORMATION CONTACT) no later 
than April 29, 2016. No commercial or promotional material will be 
permitted to be presented or distributed at the public workshop.
    FDA is holding this public workshop to obtain information on 
current and anticipated uses for LC/MS as well as different validation 
approaches. In order to permit the widest possible opportunity to 
obtain public comment, FDA is soliciting either electronic or written 
comments on all aspects of the public workshop topics. For the deadline 
for submitting comments related to this public workshop, see DATES.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see ADDRESSES). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

    Dated: March 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05220 Filed 3-8-16; 8:45 am]
BILLING CODE 4164-01-P