Document ID: FDA-2016-N-0610-0002
Agency: fda
Document Type: Notice
Title: Mass Spectrometry in the Clinic: Regulatory Considerations Surrounding Validation of Liquid Chromatography-Mass Spectrometry Based Devices; Public Workshop; Reopening of Comment Period
Posted Date: 2016-04-29T04:00Z

[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25678-25679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10106]

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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; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice of a public workshop that appeared in the 
Federal Register of March 9, 2016. In the notice of the public 
workshop, FDA requested comments on the workshop topics concerning the 
use of liquid chromatography/mass-spectrometry (LC/MS)-based in vitro 
diagnostic devices (IVDs) in the clinical laboratory. The Agency is 
taking this action in response to requests to allow interested persons 
additional time to submit comments.

DATES: FDA is reopening the comment period for the notice of public 
workshop published March 9, 2016. Submit either electronic or written 
comments by June 2, 2016.

ADDRESSES: 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-0610 for ``Mass Spectrometry in the Clinic: Regulatory 
Considerations Surrounding Validation of Liquid Chromatography-Mass 
Spectrometry Based Devices.'' 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

[[Page 25679]]

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, julia.lathrop@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 9, 2016, 
(81 FR 12511), FDA published a notice of a public workshop with a 
deadline of April 20, 2016, to request comments on the workshop topics 
concerning the use of LC/MS-based IVDs in the clinical laboratory. 
Comments on the public workshop topics will inform FDA's development 
and validation of LC/MS-based devices, especially validation 
considerations for protein- and peptide-based LC/MS devices.
    FDA is reopening the comment period for the notice of the public 
workshop until June 2, 2016. The Agency believes that the extension 
allows adequate time for interested persons to submit comments without 
significantly delaying decision making on these important issues.

    Dated: April 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10106 Filed 4-28-16; 8:45 am]
 BILLING CODE 4164-01-P